RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
Launched by WAYNE STATE UNIVERSITY · May 15, 2020
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether taking choline supplements during pregnancy can help reduce the negative effects of drinking alcohol while pregnant. Fetal Alcohol Spectrum Disorders (FASD) are serious conditions that can happen when a mother drinks alcohol during pregnancy, affecting the baby's growth and development. Researchers are looking for heavy-drinking pregnant women, particularly in a rural area of South Africa, to participate in this study. Eligible participants must be at least 18 years old, in their first 20 weeks of pregnancy, and currently consuming alcohol heavily. They should also be getting less than 1 gram of choline in their daily diet.
If you join the study, you will be randomly assigned to either receive a daily choline supplement or a placebo (a pill with no active ingredients) until your baby is born. The goal is to see if the choline can help improve your baby's memory and growth after birth. Throughout the trial, researchers will monitor how well participants follow the study rules and gather information about their backgrounds to help improve future studies. This research could lead to better support for mothers and babies affected by alcohol use during pregnancy.
Gender
ALL
Eligibility 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
About Wayne State University
Wayne State University, a distinguished public research institution located in Detroit, Michigan, is committed to advancing health and science through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, the university leverages its robust academic resources and expert faculty to conduct clinical trials that aim to improve patient outcomes and contribute to the body of medical knowledge. Wayne State University fosters a rigorous research environment, ensuring adherence to ethical standards and regulatory compliance while striving to translate research findings into practical applications that benefit diverse communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cape Town, Western Cape, South Africa
Patients applied
Trial Officials
Sandra W Jacobson, PhD
Principal Investigator
Wayne State University
Joseph L Jacobson, PhD
Principal Investigator
Wayne State University
Ernesta M Meintjes, PhD
Principal Investigator
University of Cape Town Faculty of Health Sciences
R. Colin Carter, MD, MMSc
Principal Investigator
Columbia University Vagelos College of Physicians and Surgeons
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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