Phosphatidylcholine Supplementation in Infants

Phase 1

Withdrawn

• Conditions: Schizophrenia; Diminished P50 Sensory Gating
• Interventions: Drug: phosphatidylcholine supplementation; Drug: placebo

• Registration Number: NCT01905605
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-23
• Study Start: 2013-09
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phosphatidylcholine supplementation	phosphatidylcholine supplementation	Phosphatidylcholine supplementation to be administered BID for 8 weeks
placebo supplementation	placebo	Placebo to be administered BID for 8 weeks

Primary Outcome Measures

Name	Time	Method
Ratio of P50 auditory sensory gating	8 weeks post initiation of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	4 weeks and 8 weeks after initiation of intervention	Percentage of infants with adverse events

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States