Pilot Study of Prenatal Choline Supplementation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Placebo
  Provided in beverage form
• Пищевая добавка Choline bitartrate
  Provided in beverage form.

Первичные конечные точки

• Infant recognition memory [Срок оценки: 12 months]
• Postnatal infant weight gain [Срок оценки: 6.5 months]
• Postnatal growth in infant head circumference [Срок оценки: 6.5 months]

Вторичные конечные точки (2)

• Infant information processing speed [Срок оценки: 12 months]
• Postnatal growth in infant length [Срок оценки: 6.5 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

ЮАР · 1 центр

• University of Cape Town — Cape Town

Идентификаторы

NCT: NCT07699393 · UCTCHOLINERCTPHASEB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗