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RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure

RecruitingPhase 2Ages 18 Years - 45 YearsAllWayne State University
NCT04395196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders. Animal studies have shown that choline supplementation can mitigate effects of PAE on growth and development. Choline, an essential nutrient, serves as a methyl-group donor for DNA methylation and is a constituent of the neurotransmitter acetylcholine and a precursor to major components of cell membranes. In an R21 feasibility trial, 70 heavy drinkers were randomly assigned to receive a daily dose of 2g of choline or a placebo from initiation of antenatal care to delivery in Cape Town, South Africa, where the incidence of heavy drinking during pregnancy and fetal alcohol syndrome are among the highest in the world. When compared with infants in the placebo arm, infants in the

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📋 Eligibility rules (as published)
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
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What it tests

  • Choline bitartrate
  • Placebo
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Where

1 site
University of Cape Town Faculty of Health Sciences
Cape Town, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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