Prenatal Choline Supplementation to Support Infant Growth and Brain Development in Non-Drinking Pregnant Women A Randomized, Placebo-Controlled Pilot Study

What this Trial Is About

Researchers are evaluating the effects of prenatal choline supplementation on infant growth and brain development in pregnant women who abstain from alcohol. This pilot phase 2 study compares the outcomes of choline supplementation versus placebo in healthy pregnant women without prenatal alcohol exposure, aiming to understand potential benefits on infant recognition memory, postnatal growth, and neurobehavioral development. Participants will receive either 2 grams of choline cation daily or a placebo beverage identical in appearance, taste, and smell. The study follows a randomized, double-blind, placebo-controlled design and plans to enroll 50 pregnant women with singleton pregnancies who have abstained from alcohol. The protocol mirrors a previous study involving heavy-drinking pregnant women, allowing comparison of cholines effects in non-drinking mothers. During the study, infants will be assessed for recognition memory at 12 months and growth measurements weight, head circumference, and length at 6.5 months. Additional evaluations include infant information processing speed and eyeblink conditioning. Researchers will monitor participants through scheduled visits to collect developmental data, track adherence, and ensure safety. The studys total duration extends through infant assessments up to 12 months of age.

Pilot Study of Prenatal Choline Supplementation