Fetal Alcohol Spectrum DisordersPhase 2NCT01911299
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
A Phase 2 study testing Choline in people with Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, run by San Diego State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome
- What is being tested?
- Choline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion)
- English as primary language
Who cannot join
- Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
- History of neurological condition (e.g., epilepsy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Behavioral Teratology, San Diego State University
San Diego, California, 92120
About this study
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.
Read the detailed description
Despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive treatments for individuals with FASD. This pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. Choline is an essential nutrient, necessary for brain and behavioral development. Animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. The present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. These data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol-related Neurodevelopmental Disorder, Prenatal Alcohol Exposure
- Being tested
- Choline, placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water
- Keywords
- Choline, Glycerophosphocholine, Choline alphoscerate, Fetal alcohol spectrum disorders, Fetal alcohol syndrome, Partial fetal alcohol syndrome, Alcohol-related neurodevelopmental disorder, Prenatal alcohol exposure, Fetal Alcohol Effects, Pregnancy Complications, Alcohol-Induced Disorders, Alcohol-Related Disorders, Central Nervous System Agents, Therapeutic Uses
- Medical subject headings
- Fetal Alcohol Spectrum Disorders, Pregnancy Complications, Alcohol-Induced Disorders, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholineDietary supplement
5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized waterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Choline | Experimental | Liquid glycerophosphocholine (GPC) supplement Receives: Dietary Supplement: Choline |
| Placebo | Placebo comparator | Liquid placebo supplement Receives: Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)
Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Thomas, San Diego State University
- Investigators
- Jennifer D. Thomas, Ph.D., Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911299
- Sponsor's protocol ID
- CBT-choline-1
- Status last verified
- Jul 2014
- First submitted
- 26 Jul 2013
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nguyen TT, Risbud RD, Mattson SN, Chambers CD, Thomas JD. Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders. Am J Clin Nutr. 2016 Dec;104(6):1683-1692. doi: 10.3945/ajcn.116.142075. Epub 2016 Nov 2.
PubMed 27806977
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01911299
- Acronym / sponsor ID
- CBT-choline-1
- Conditions
- Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol-related Neurodevelopmental Disorder, Prenatal Alcohol Exposure
- Keywords
- Choline, Glycerophosphocholine, Choline alphoscerate, Fetal alcohol spectrum disorders, Fetal alcohol syndrome, Partial fetal alcohol syndrome, Alcohol-related neurodevelopmental disorder, Prenatal alcohol exposure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.
Detailed description
Despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive treatments for individuals with FASD. This pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. Choline is an essential nutrient, necessary for brain and behavioral development. Animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. The present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. These data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choline | Experimental | Dietary Supplement: CholineLiquid glycerophosphocholine (GPC) supplement |
| Placebo | Placebo comparator | Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized waterLiquid placebo supplement |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion)
- English as primary language
Key exclusion criteria (2 listed)
- Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
- History of neurological condition (e.g., epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choline5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline | Dietary supplement | Choline |
| placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water | Dietary supplement | Placebo |
Primary outcome
Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention
Time frame: Baseline and 6 weeks
1 secondary outcome
Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Derived from this study: PubMed 27806977Nguyen TT, Risbud RD, Mattson SN, Chambers CD, Thomas JD. Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders. Am J Clin Nutr. 2016 Dec;104(6):1683-1692. doi: 10.3945/ajcn.116.142075. Epub 2016 Nov 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer D. Thomas, Ph.D. principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Choline in people with Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.