Supplemental Choline and Brain Development in Humans

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

Studies have shown that choline is a necessary part of the human diet. Choline is important in making membranes for all the cells in the body, and for making chemicals that are responsible for nerve function. Studies have also shown that choline improves memory of rats when they are given choline at early stages in their lives. The purpose of this study is to find out whether choline supplementation (provided as a choline dietary supplement) in pregnant women will improve memory function of their babies after they are born. In this study, we hypothesize that high dietary choline consumption during pregnancy and lactation will: 1. Increase maternal choline concentration in plasma 2. Increase breast milk choline concentration 3. Enhance memory performance in the children born of supplemented mothers

Key facts

Study ID

NCT00678925

Run by

The Gerber Foundation

People needed

150

Starts

2004-12-01

Expected to finish

2008-05-01

Last updated by the study team

2010-06-22

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Less than 18 weeks pregnant
• Intends to breastfeed
• Receives regular prenatal care
• Takes a prenatal vitamin

You may not qualify if…

• Uses tobacco or illicit drugs
• Consumes alcohol
• History of chronic illness
• History of allergy to soy or corn
• Difficulty swallowing large capsules
• BMI <18 or >35
• Pregnant with more than 1 fetus

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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