Supplemental Choline and Brain Development in Humans

NCT00678925 | Completed DMC

• 1 other identifier: 04-1752 (completed)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Increase maternal choline concentration in plasma
2. 2.Increase breast milk choline concentration
3. 3.Enhance memory performance in the children born of supplemented mothers

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Infant working memory

  10 months & 12 months of age

Secondary Outcomes (2)

• Breast milk choline concentration

  45 & 90 days postpartum

• Plasma choline concentrations

  20 & 30 wks pregnancy, 45 & 90 days postpartum

Study Arms (2)

1

ACTIVE COMPARATOR

Choline supplement given from 18-weeks pregnancy through 90 days postpartum

Dietary Supplement: Phosphatidylcholine

2

PLACEBO COMPARATOR

Placebo capsules given from 18 weeks pregnancy through 90 days postpartum

Dietary Supplement: Corn oil placebo

Interventions

Phosphatidylcholine DIETARY_SUPPLEMENT

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

Also known as: PhosChol

1

Corn oil placebo DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• The Gerber Foundation: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (2)

• Cheatham CL, Goldman BD, Fischer LM, da Costa KA, Reznick JS, Zeisel SH. Phosphatidylcholine supplementation in pregnant women consuming moderate-choline diets does not enhance infant cognitive function: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2012 Dec;96(6):1465-72. doi: 10.3945/ajcn.112.037184. Epub 2012 Nov 7.

  PMID: 23134891 DERIVED

• Fischer LM, da Costa KA, Galanko J, Sha W, Stephenson B, Vick J, Zeisel SH. Choline intake and genetic polymorphisms influence choline metabolite concentrations in human breast milk and plasma. Am J Clin Nutr. 2010 Aug;92(2):336-46. doi: 10.3945/ajcn.2010.29459. Epub 2010 Jun 9.

  PMID: 20534746 DERIVED

MeSH Terms

Interventions

Phosphatidylcholines

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: December 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2008
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

US (1)