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New treatment option for Fetal Alcohol Spectrum Disorders
Official title RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
ClinicalTrials.gov ID: NCT04395196
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Current choline dietary intake \<1 g/day
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cape Town, Western Cape, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cape Town, Western Cape, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.