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Clinical trial

Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age

ID
Name
16-1510
Description
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.
Trial arms
Trial start
2017-06-12
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Choline
Mothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.
Arms:
Drug: Choline
Other names:
Phosphatidylcholine
Placebo
Mothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.
Arms:
Participants will take placebo
Other names:
Corn oil every day in place of choline
Size
600
Primary endpoint
Behavior rated on the Child Behavior Checklist.
4 Years of age
Eligibility criteria
Inclusion Criteria: * General Health: Other than pregnancy related illnesses, physically healthy expectant mothers * ages 18-45 years * prepregnancy BMI\>18 and \<45 Exclusion Criteria: * Prior history of fetal death * Current personal history of chronic infections, including HIV * Current personal or family history out to first degree relatives of 1. Trimethylaminuria 2. Homocystinuria * Primary language other than English or Spanish * Evidence of noncompliance
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2023-09-28

1 organization

1 product

2 indications

Organization
University of Colorado Denver
Product
Choline
Indication
Child Development
Indication
Prenatal Stress