Phosphatidylcholine Supplementation in Infants

Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating

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.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia; Diminished P50 Sensory Gating
• Intervention / Treatment: Drug: phosphatidylcholine supplementation; Drug: placebo

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of planned dietary supplement	Percentage of planned dietary supplement given to the infant	8 weeks
Change in serum choline, betaine, and dimethylglycine levels		Randomization and 8 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Robert Freedman, MD, University of Colorado, Denver

Publications and helpful links

Helpful Links

• University of Colorado School of Medicine Developmental Psychiatry Research Lab

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2013
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 18, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 13-2182