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

Primary Objective

Primary Objective: Assess whether parental rating of problems on the Attention and Social Withdrawal indices of the Child Behavior Checklist at 4 years of age for children of mothers who received prenatal phosphatidylcholine supplementation are lower, compared to children whose mothers received placebo.

Study category: Behaviors and Mental Health

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Details
Age

Adult

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Prevention

Scope

Local

Locations

Colorado Research Center
Denver Health Medical Center
Department Specific Free Standing Clinic
University of Colorado Hospital

Principal Investigator
Camille Hoffman,  MD, MSc

Camille Hoffman, MD, MSc

Study ID

Protocol Number: 16-1510

ClinicalTrials.gov: NCT03028857

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