Prenatal choline supplementation to reduce effects of alcohol on fetal development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.