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Supplemental Choline and Brain Development in Humans

NCT00678925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-06-22

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Phosphatidylcholine

850 mg per day from 18 weeks pregnancy through 90 days postpartum

DIETARY_SUPPLEMENT

Corn oil placebo

Placebo capsules containing corn oil given from 18 weeks pregnancy through 90 days postpartum

Sponsors & Collaborators

  • Egg Nutrition Center

    collaborator OTHER

  • The Gerber Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-12-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00678925 on ClinicalTrials.gov