Phosphatidylcholine Supplementation in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-01-31

Brief Summary

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Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.

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Detailed Description

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Conditions

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Schizophrenia Diminished P50 Sensory Gating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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phosphatidylcholine supplementation

Phosphatidylcholine supplementation to be administered BID for 8 weeks

Group Type EXPERIMENTAL

phosphatidylcholine supplementation

Intervention Type DRUG

phosphatidylcholine concentrate 700 mg twice per day

placebo supplementation

Placebo to be administered BID for 8 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day

Interventions

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phosphatidylcholine supplementation

phosphatidylcholine concentrate 700 mg twice per day

Intervention Type DRUG

placebo

placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day

Intervention Type DRUG

Other Intervention Names

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Phosphatidylcholine, phosphatidylcholine concentrate Corn Oil

Eligibility Criteria

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Inclusion Criteria

* Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks
* Diminished P50 sensory gating (ratio greater than or equal to 0.50)

Exclusion Criteria

* No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)
* Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use

Minimum Eligible Age

1 Week

Maximum Eligible Age

7 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes