Phosphatidylcholine Supplementation in Infants

Study Overview
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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.

Official Title
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Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating

Conditions
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Schizophrenia, Diminished P50 Sensory Gating

Intervention / Treatment
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* Drug: phosphatidylcholine supplementation
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 7 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: phosphatidylcholine supplementation<br>Phosphatidylcholine supplementation to be administered BID for 8 weeks | Drug: phosphatidylcholine supplementation<br>* phosphatidylcholine concentrate 700 mg twice per day<br>* Other names: Phosphatidylcholine, phosphatidylcholine concentrate;|
| Placebo Comparator: placebo supplementation<br>Placebo to be administered BID for 8 weeks | Drug: placebo<br>* placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day<br>* Other names: Corn Oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of P50 auditory sensory gating | In an auditory evoked potential paradigm while in active sleep (the infant equivalent of rapid eye movement sleep) with two identical sounds presented 500 ms apart, the ratio of the amplitude of the P50 response to the second sound divided by the amplitude of the P50 response to the first sound. | 8 weeks post initiation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Percentage of infants with adverse events | 4 weeks and 8 weeks after initiation of intervention |