Prenatal choline supplementation to reduce effects of alcohol on fetal development
A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development
This study is testing if giving pregnant women who drink heavily a supplement called choline can help protect their babies from the harmful effects of alcohol during pregnancy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Cape Town, Western Cape) |
| Trial ID | NCT04395196 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of prenatal choline supplementation on pregnant women who are heavy drinkers, aiming to mitigate the adverse impacts of prenatal alcohol exposure on fetal development. Participants will receive either choline bitartrate or a placebo from the start of antenatal care until delivery. The study is conducted in Cape Town, South Africa, where the rates of heavy drinking during pregnancy are notably high. The trial builds on previous animal studies suggesting that choline can improve growth and neurodevelopment in infants exposed to alcohol in utero.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older, less than 20 weeks gestation, who are heavy drinkers and have low dietary choline intake.
Not a fit: Patients who are not heavy drinkers or those with serious pre-existing medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a nutritional intervention to improve outcomes for infants at risk of fetal alcohol spectrum disorders.
How similar studies have performed: Previous studies have shown promising results with choline supplementation in animal models, but this approach in humans is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 yr * ≤20 wk gestation * Singleton pregnancy * Currently heavy drinking (average of ≥15 ml AA/day or binge drinking (≥4 standard drinks/occasion) on at least 1.5 occasions/month on average since becoming pregnant) * Current choline dietary intake \<1 g/day * Language fluency in English or Afrikaans Exclusion Criteria: * Use of methamphetamine or other illicit drugs other than marijuana during the past year * HIV positive * Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems) * Having another child enrolled in the trial from a previous pregnancy * Plans for mother or child to move away from the area prior to study completion
Where this trial is running
Cape Town, Western Cape
- University of Cape Town Faculty of Health Sciences — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Sandra W Jacobson, PhD — Wayne State University
- Study coordinator: R. Colin Carter, MD, MMSc
- Email: rcc2142@cumc.columbia.edu
- Phone: +16176949902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.