Safety and Effectiveness of Taking Choline Supplements During Pregnancy for Improving Infant Brain Development
Double-blind Trial of Phosphatidylcholine During Pregnancy and Infant Serum Choline Levels
2 other identifiers
interventional
351
1 country
1
Brief Summary
This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether choline supplementation has an effect on infant development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pregnancy
Started Jun 2006
Longer than P75 for phase_1 pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2006
CompletedFirst Posted
Study publicly available on registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedSeptember 2, 2020
August 1, 2020
10.8 years
May 30, 2006
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sensory Gaiting (P50)
Measured at birth, 1 month and 3 months after birth
Study Arms (2)
1
PLACEBO COMPARATORParticipants will take placebo
2
ACTIVE COMPARATORParticipants will take choline
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant
- Between 10 and 18 weeks gestational age
- Healthy
- Diagnosis of psychosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver
Aurora, Colorado, 80045, United States
Related Publications (2)
Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7.
PMID: 26651393DERIVEDRoss RG, Hunter SK, McCarthy L, Beuler J, Hutchison AK, Wagner BD, Leonard S, Stevens KE, Freedman R. Perinatal choline effects on neonatal pathophysiology related to later schizophrenia risk. Am J Psychiatry. 2013 Mar;170(3):290-8. doi: 10.1176/appi.ajp.2012.12070940.
PMID: 23318559DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Freedman, MD
University of Colorado, School of Medicine,
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2006
First Posted
June 1, 2006
Study Start
June 1, 2006
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
September 2, 2020
Record last verified: 2020-08