Status:
RECRUITING
RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
University of Cape Town
Columbia University
Conditions:
Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
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 spec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2028
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT04395196
Start Date
April 13 2023
End Date
May 15 2028
Last Update
April 1 2025
Active Locations (1)
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1
University of Cape Town Faculty of Health Sciences
Cape Town, Western Cape, South Africa, 7925