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โ† Trials
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Pilot Study of Prenatal Choline Supplementation

RecruitingPhase 2Ages 18 Years - 45 YearsAllWayne State University
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In plain words

What the trial is, and whether it could suit you

A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed. The study design was based on a pilot feasibility study in 70 heavy-drinking pregnant women. Infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning than those in the placebo arm. Infants born to both the choline- and placebo-treated mothers were small at birth, but those in the choline arm showed considerab

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 yr * โ‰ค20 wk gestation * Singleton pregnancy * Abstinence from alcohol since conception (by report) * 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

  • Placebo
  • Choline bitartrate
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Where

1 site
University of Cape Town
Cape Town, South Africa
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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