Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00332124
First received: May 30, 2006
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.


Condition Intervention Phase
Pregnancy
Child Development
Drug: Choline
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Sensory Gaiting (P50) [ Time Frame: Measured at birth, 1 month and 3 months after birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: June 2006
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Participants will take placebo
Dietary Supplement: Placebo
Corn oil every day in place of choline
Active Comparator: 2
Participants will take choline
Drug: Choline
900 mg every day until birth of infant
Other Name: Polyenylphosphatidylcholine

Detailed Description:

Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.

Participants in this double-blind study will be randomly assigned to receive either placebo or 900 mg of choline daily throughout pregnancy, until delivery. Babies will then begin receiving either placebo or choline daily from the time of birth until they are 3 months old. Participants will attend a baseline study visit that will include eligibility assessment, urine collection, measurement of vital signs, dispensing of study medication, and an ultrasound. Subsequent study visits will occur every 4 weeks throughout pregnancy and 6 months postpartum. Vital signs will be taken, urine samples will be collected, and study medication will be given at each visit. Two blood samples will be taken between Weeks 32 and 36 of gestation. Heel sticks will be performed on babies when they are 4 and 12 weeks old. Follow-up visits will be held every 6 months until the baby is 18 months old.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Between 10 and 18 weeks gestational age
  • Healthy
  • Diagnosis of psychosis

Exclusion Criteria:

  • Use of any tobacco or nicotine product
  • Drinks more than 1 alcoholic drink per day
  • Use of illicit drugs
  • History of trimethylaminuria
  • History of kidney disease
  • History of liver disease
  • History of pre-pregnancy diabetes
  • History of Parkinson's disease
  • History of fetal death, fetal/infant congenital malformation, or fetal/infant genetic abnormality
  • Evidence of noncompliance to study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332124

Contacts
Contact: Amber Americanos, RN 303.724.6205 amber.americanos@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Amber Americanos, RN       amber.americanos@ucdenver.edu   
Principal Investigator: Randy Ross, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Randy Ross, MD University of Colorado, School of Medicine, Department of Psychiatry
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00332124     History of Changes
Other Study ID Numbers: 04-0678, DATR A5-ETPD
Study First Received: May 30, 2006
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014