A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development: Pilot Arm for Non-Drinking Women
| Registry | NCT07699393 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | Wayne State University (Other); collaborators: Columbia University, University of Cape Town |
| Conditions | Brain Development, Choline Nutrition |
| Interventions | Placebo, Choline bitartrate (Dietary supplement) |
| Dates | start 2026-07-08 (estimated), primary completion 2027-10-15 (estimated), completion 2028-05-15 (estimated), first posted 2026-07-13, last updated 2026-07-14 |
| Locations | 1 site in South Africa |
Related Papers Related Patents Related Grants Related Experts
All trials for Brain Development All trials for Choline Nutrition All trials of Placebo All trials of Choline bitartrate
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 considerable catch-up growth in weight and head circumference by 6.5 months, which persisted through 12 months. At 12 months, infants in the choline arm showed markedly better recognition memory compared to placebo-treated on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ. Of note, infants with heavy prenatal alcohol exposure whose mothers were in the active choline treatment arm performed better on FTII novelty preference neurobehavioral testing than infants in an observational study that was running in parallel who had no prenatal alcohol exposure. These pilot findings indicate that any beneficial effects of prenatal choline supplementation seen may be due in part or entirely due to general beneficial effects on fetal brain development rather than mechanisms that are specific to the teratogenic effects of alcohol. Thus, the aim of this pilot study is to enroll and randomize 50 alcohol-abstaining pregnant women to participate in an identical study protocol (same study procedures and primary and secondary outcomes) to NCT04395196, which includes only alcohol-consuming pregnant women. Effect sizes between this pilot, non-drinking group and the larger study of alcohol-consuming women will be compared to explore the degree to which prenatal choline supplementation benefits growth and neurobehavior in infants without prenatal alcohol exposure and to explore the degree to which beneficial treatment effects of choline are specific to prenatal alcohol exposure.
The study protocol will be identical to NCT04395196 except for sample size (goal = 50 pregnant women and their infants) and that instead of including heavy-drinking pregnant women, inclusion criteria require that women have fully abstained from alcohol during pregnancy at the time of randomization. All other inclusion/exclusion criteria and study procedures are identical.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| High-dose choline supplementation | Experimental | Dietary Supplement: Choline bitartrate | 2 g choline cation per day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo | Placebo identical to active treatment in appearance, taste, and smell. |
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * Age ≥18 yr * ≤20 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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Cape Town | Cape Town | South Africa | Recruiting |