This page shows what was measured, who it was measured in, and what that does not settle.
What Choline does in the body
VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
The exact mechanism of action of diazoxide choline in the treatment of hyperphagia in patients 4 years of age and older with Prader-Willi syndrome (PWS) is unknown.
Why people take it. VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Not usually supervised: sold as a supplement or food ingredient where recorded. That is a legal category, not a safety judgement.
What the registries record it as
The supplement label database classes it as vitamin, under the name Choline.
Its recorded molecular formula is C8H6ClN2O2S•C5H14NO, weighing 333.83 g/mol.
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
97 registered substances share the start of this name, which is why a search for it can return more than one thing.
FDA substance registry · 7DKH3NEJ7F · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 86 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 9 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer1 registered performance measure of this kind.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Focus
cognitive function; cognitive functions
Pain
numerical rating scale pain
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
1 registered performance measure of this kind.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Length-for-age Z-score (LAZ) at 12 months of age
✗ The study did not show it
Who was studied
NCT03683667
How many people
5283
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Wide Range Achievement Test (WRAT-5) Composite Score
✗ The study did not show it
Who was studied
NCT07695883
How many people
3000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Total recovery at three months of onset, based on a global test analysis including NIHSS, mRS and Barthel Index
✗ The study did not show it
Who was studied
NCT00331890
How many people
2298
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Diagnostic accuracy of Fluorocholine PET/CT
✗ The study did not show it
Who was studied
NCT04150458
How many people
2000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Birth weight of newborn
✗ The study did not show it
Who was studied
NCT04012177
How many people
1884
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Gestational duration
✗ The study did not show it
Who was studied
NCT05949190
How many people
1660
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Mouse, Rat, Dog. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
numerical rating scale pain
Measured
Things only a test, a scale or a device shows.
urinary monomethyl arsenic
urinary inorganic arsenic
urinary dimethyl arsenic
Meaningful
Things that change how a life goes, not only a number.
cognitive function
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (4)
primary outcome measure
birth weight of newborn
objective response rate
cognitive functions
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Livita™ liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Use of VYKAT XR for this indiction is supported by efficacy data from an adequate and well-controlled study that included pediatric patients with PWS [see Clinical Studies (14) ] and safety data from additional studies that included pediatric patients with PWS [see Adverse Reactions (6) ] , and the information on this use is described throughout the labeling.”
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
On older people, the label states: “Clinical studies of VYKAT XR did not include any subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.”
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
On people who are pregnant, the label states: “Risk Summary Available data from case reports with diazoxide use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal outcomes.”
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
On people who are breastfeeding, the label states: “Risk Summary Diazoxide is present in human milk.”
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
On people with reduced liver function, the label states: “VYKAT XR has not been studied in patients with hepatic impairment.”
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
On people with reduced kidney function, the label states: “VYKAT XR has not been studied in patients with renal impairment.”
US prescribing information · 0e745e85-9512-e360-e063-6394a90aebf1 · read 2026-09-12
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (9)
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Not usually supervised: sold as a supplement or food ingredient where recorded. That is a legal category, not a safety judgement.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as a supplement ingredient; no medicines register records an approval.
No source is stored against this line.
What is in the pack
Sold as tablet, liquid, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Choline appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 61 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
dehydration — 10 reaction mentions
condition aggravated — 9 reaction mentions
dysphagia — 9 reaction mentions
mental disorder — 8 reaction mentions
muscle spasms — 7 reaction mentions
normal newborn — 5 reaction mentions
pneumonia aspiration — 4 reaction mentions
foetal growth restriction — 3 reaction mentions
implant site erosion — 3 reaction mentions
muscle spasticity — 3 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
13 products list this as an active ingredient in the United States drug directory. None of them contains it on its own, so nothing on this page can separate it from what it is combined with.
FDA National Drug Code directory · 59088-172 · read 2026-08-29
They are sold as liquid, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 59088-172 · read 2026-08-29
12 published labels name it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.
US prescribing information · 52d5eee7-8146-cc62-e063-6394a90a8c3f · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 52d5eee7-8146-cc62-e063-6394a90a8c3f · read 2026-08-29
4631 marketed supplement labels list this ingredient, classed as mineral, other combinations and vitamin.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Vitalux is oral at HOW SUPPLIED: Vitalux™ caplets are supplied as beige, oblong, film-coated caplets in bottles containing 30 caplets – NDC 59088-139-54., recorded as fda label in effect 2026-06-02 in the United States.
US prescribing information · 52d5eee7-8146-cc62-e063-6394a90a8c3f · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (11)
Q1
What did Choline's largest trial (1884 people) and its longest (19 years) measure?
1884 people in Choline's largest registered study, 19 years in its longest registered window, measuring Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite. ClinicalTrials.gov · 2026-09-01
9 na, 8 phase2, 6 phase1, 3 phase3, 3 phase4, 1 early phase1; NCT01731236; 2029-12; no ageing endpoint recorded. Last human test completed 2026, NCT06924541.
Interpretation These counts include studies where Choline was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
na
9
phase2
8
phase1
6
phase3
3
phase4
3
early phase1
1
1 more recorded row
Last recorded human testNCT06924541
2026-03-01
recorded 2026-09-01 · last checked 2026-09-04
Q2
From C. elegans to human: where has Choline shown lifespan?
Interpretation Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite — the recorded outcome words.
Show the evidence
C. elegans
lifespan
mouse
lifespan
rat
mechanism-only
dog
biomarker
humanNCT03039023
biomarker; Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite; 28
recorded 2026-09-01 · last checked 2026-09-04
Q3
More Choline was worse in human: at what point?
U-shaped in human: "RCS analyses further revealed a significant nonlinear association between total choline intake and diabetes risk, with a U-shaped association in men and a J-shaped association in women (all <i>P</i> for nonlinearity <0.001)." Europe PMC · dose-response search · 2026-07-09
6 recorded sentences naming Choline; U-shaped, dose-response
Show the evidence
U-shaped
PMID 41773536
"RCS analyses further revealed a significant nonlinear association between total choline intake and diabetes risk, with a U-shaped association in men and a J-shaped association in women (all <i>P</i> for nonlinearity <0.001)."
PMID 41365816
"A U-shaped association was observed between dietary choline intake and all-cause mortality (<i>P</i><sub>for non-linearity</sub> < 0·0001)."
PMID 41365816
"These findings indicate a U-shaped relationship between dietary choline intake and all-cause mortality in individuals with diabetes, with intakes between 286·77 and 538·86 mg/d associated with the lowest risk - providing potential implications for dietary guidance in diabetes management."
dose-response
PMID 41773536
"Significant nonlinear dose-response associations were also observed for water-soluble and lipid-soluble choline intake in men and water-soluble choline intake in women."
PMID 42537552
"A one-stage random-effects dose-response meta-analysis with restricted cubic splines was used to evaluate the effect of nominal choline chloride dose on blood concentrations of free fatty acids, β-hydroxybutyrate, glucose, total cholesterol, triglycerides, and aspartate aminotransferase."
PMID 42537552
"However, the dose-response curves are based on nominal choline chloride equivalents and should not be interpreted as estimates of absorbed or bioavailable choline supply."
recorded 2026-07-09 · last checked 2026-09-04
Q4
Could one person measure Choline's effect on numerical rating scale pain?
Numerical rating scale pain: measured in Choline's trials.
Interpretation numerical rating scale pain is the recorded endpoint.
Show the evidence
biomarkers
numerical rating scale pain; 2026-09-01
primary outcome measure; 2026-09-01
urinary monomethyl arsenic; 2026-09-01
urinary inorganic arsenic; 2026-09-01
urinary dimethyl arsenic; 2026-09-01
cognitive function; 2026-09-01
3 more recorded rows
biomarkers
birth weight of newborn; 2026-09-01
biomarkers
objective response rate; 2026-09-01
biomarkers
cognitive functions; 2026-09-01
human trials at or under30
7
Not recorded for this substance
a recorded half-life
smallest human trial
14; NCT04764162; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED
Q5
Which of birth weight of newborn, cognitive function and cognitive functions did Choline's trials measure?
birth weight of newborn, cognitive function and cognitive functions lead 9 outcome terms across Choline's trials. ClinicalTrials.gov · 2026-09-01
Interpretation urinary inorganic arsenic, urinary dimethyl arsenic, cognitive function, birth weight of newborn, objective response rate and cognitive functions follow.
Show the evidence
numerical rating scale pain
1
primary outcome measure
1
urinary monomethyl arsenic
1
urinary inorganic arsenic
1
urinary dimethyl arsenic
1
cognitive function
1
3 more recorded rows
birth weight of newborn
1
objective response rate
1
cognitive functions
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of Choline's 7 ongoing trials reports first?
"CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease"; n 100; "Primary Outcome Measure"; 2029-12
NCT04395196
"RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure"; n 288; "Infant recognition memory"; 2028-05-15
NCT05076682
"Reverse Triple Negative Immune Resistant Breast Cancer"; n 80; "Objective Response Rate (ORR)"; 2027-03-31
NCT05108974
"Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study"; n 62; "Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)"; 2027-07-31
NCT06379971
"Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development"; n 140; "Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index"; 2029-04-30
NCT06527391
"Choline and Iron Deficiency"; n 300; "Elicited Imitation score"; 2027-09-21
1 further recorded trialNCT07699393
"Pilot Study of Prenatal Choline Supplementation"; n 50; "Infant recognition memory"; 2028-05-15
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which 8 trials of Choline posted no result?
Posted no result
8 of 8 completed trials
Registrations
NCT01911299, NCT02371993, NCT01722448, NCT00332124, NCT03249259 and NCT06200883, and 2 more
Completion dates
oldest 2014-05; newest 2023-11-21
Show the evidence
Trial
NCT01911299
2014-05
NCT02371993
2015-06
NCT01722448
2015-08
NCT00332124
2017-03
NCT03249259
2019-09-30
NCT06200883
2023-11-01
2 further recorded trials
NCT03327805
2023-11-21
NCT03646175
2023-11-21
Q8
At the median, Choline's trials enrolled 59 people — anything larger?
Median enrolment
59
Largest enrolment
1884
Registered trials counted
28
Q9
What do 61 spontaneous reports say about Choline — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Choline appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 61 reaction mentions were counted: dehydration 10; condition aggravated 9; dysphagia 9; mental disorder 8. open-targets-adr · CHEMBL920 · 2026-06-24
Show the evidence
dehydration
10
condition aggravated
9
dysphagia
9
mental disorder
8
muscle spasms
7
normal newborn
5
4 more recorded rows
pneumonia aspiration
4
foetal growth restriction
3
implant site erosion
3
muscle spasticity
3
recorded 2026-06-24 · last checked 2026-09-04
Q10
Was Choline studied with fasting and exercise?
fasting and exercise are named in Choline's label sentences: "In two randomized, double-blind, placebo-controlled studies, acute and short-term dietary choline increased TMAO without affecting insulin sensitivity, glucose tolerance, or fasting glucose and insulin." openfda-label+europepmc · 2026-06-18
2 recorded statements; fasting, exercise
Show the evidence
fasting
In two randomized, double-blind, placebo-controlled studies, acute and short-term dietary choline increased TMAO without affecting insulin sensitivity, glucose tolerance, or fasting glucose and insulin.
exercise
An exploratory analysis of choline and protein intake from 3-d diet records and measures of 36 serum choline and carnitine metabolites in early (12-17 wk) and late (36-38 wk) pregnancy was conducted in participants from the Be Healthy in Pregnancy study randomized to high dairy protein+walking exercise or usual care.
recorded 2026-06-18 · last checked 2026-09-04
Q11
What is recorded about Choline and mTOR?
"In summary, our study identifies LAMTOR1 as a key protein target of ACA, revealing a potential therapeutic avenue for MAFLD by modulating autophagy via the LAMTOR1-MTORC1-AMPK signaling pathway.<b>Abbreviations:</b> ACA: acacetin; ADGRE1/EMR1/F4/80: adhesion G protein-coupled receptor E1; AMPK: AMP-activated protein kinase; CDAHFD:…" — where Choline and mTOR appear together. Europe PMC · pathway abstract search · 2026-06-26
"In summary, our study identifies LAMTOR1 as a key protein target of ACA, revealing a potential therapeutic avenue for MAFLD by modulating autophagy via the LAMTOR1-MTORC1-AMPK signaling pathway.<b>Abbreviations:</b> ACA: acacetin; ADGRE1/EMR1/F4/80: adhesion G protein-coupled receptor E1; AMPK: AMP-activated protein kinase; CDAHFD: choline-deficient amino acid-defined, high-fat diet; CETSA:…"
AMPKPMID 40548398
"In summary, our study identifies LAMTOR1 as a key protein target of ACA, revealing a potential therapeutic avenue for MAFLD by modulating autophagy via the LAMTOR1-MTORC1-AMPK signaling pathway.<b>Abbreviations:</b> ACA: acacetin; ADGRE1/EMR1/F4/80: adhesion G protein-coupled receptor E1; AMPK: AMP-activated protein kinase; CDAHFD: choline-deficient amino acid-defined, high-fat diet; CETSA:…"
autophagyPMID 40548398
"In summary, our study identifies LAMTOR1 as a key protein target of ACA, revealing a potential therapeutic avenue for MAFLD by modulating autophagy via the LAMTOR1-MTORC1-AMPK signaling pathway.<b>Abbreviations:</b> ACA: acacetin; ADGRE1/EMR1/F4/80: adhesion G protein-coupled receptor E1; AMPK: AMP-activated protein kinase; CDAHFD: choline-deficient amino acid-defined, high-fat diet; CETSA:…"
sirtuinPMID 41517346
"Immunohistochemistry quantified choline acetyltransferase (ChAT), sirtuin 1 (SIRT1), and Iba-1 as indices of cholinergic function, cellular stress/inflammation modulation, and microglial activation in the facial nucleus. <b>Results</b>: Axotomy significantly reduced whisker and blink scores compared with sham."
IGF-1PMID 42202563
"Instead, choline exerted treatment-dependent modulation of IGF-1 and MSTN primarily in the pectoralis (P < 0.001), indicating that choline promotes muscle growth via the IGF-1/MSTN axis."
autophagyPMID 42506405
"Activation of the CDC42/JNK pathway and ROS/NFκB axis-related proteins, along with depressed PI3K/AKT/RAC-related proteins, indicated enhanced mitochondrial autophagy in response to NEFA. <b>Conclusions:</b> Overall, data confirmed published effects of choline on TAG accumulation, VLDL secretion, and fatty acid oxidation, while highlighting negative effects of NEFA on the respiratory electron…"
AMPK
PMID 41233636
"Furthermore, inhibition of AMP-activated protein kinase (AMPK) reduced GNMT protein expression and elevated Myc, a negative transcriptional regulator of GNMT, suggesting that choline may regulate GNMT through the AMPK/Myc axis."
PMID 41233636
"Collectively, our findings demonstrate that choline alleviates NEFA-induced lipid accumulation and hepatocellular damage by modulating lipid and bile acid metabolism through GNMT, with the AMPK/Myc/GNMT signaling axis playing a pivotal regulatory role."
sirtuinPMID 39805404
"In addition, 383 mRNAs and 25 miRNAs displayed choline × DHA interactions including synergistic effects on acute phase response signaling, and antagonistic effects on tRNA splicing, peroxisome proliferator-activated receptor α/retinoid X receptor α activation, and sirtuin signaling, NAD signaling, and RNA polymerase I transcription pathways."
NAD+PMID 39805404
"In addition, 383 mRNAs and 25 miRNAs displayed choline × DHA interactions including synergistic effects on acute phase response signaling, and antagonistic effects on tRNA splicing, peroxisome proliferator-activated receptor α/retinoid X receptor α activation, and sirtuin signaling, NAD signaling, and RNA polymerase I transcription pathways."
autophagyPMID 38911213
"We found that choline inhibited the proliferation, migration, and invasion of HCC cells by downregulating autophagy <i>in vitro</i> and <i>in vivo</i>."
sirtuin
"The role of the vagus nerve was further tested via vagotomy, with comparative analyses of choline levels in mice and mood disorder patients. <italic>Sirt3</italic> -KO mice appeared mood-related neurobehavioral changes and alterations in synaptic plasticity-related genes in the amygdala and BNST, dependent on gut microbiome composition."
mTOR
"Mechanistically, several metabolic pathways of tumor cells changed after <italic>S.fibuligera</italic> treatment, among which choline metabolism changed significantly. <italic>S.fibuligera</italic> inhibited choline metabolism of CRC cells by targeting and inhibiting the Ras/PI3K/AKT pathway, thereby reducing the expression of related metabolites, activating the AMPK pathway and inhibiting the…"
recorded 2026-06-26 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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