search
Back to results

Phosphatidylcholine Supplementation in Infants

Primary Purpose

Schizophrenia, Diminished P50 Sensory Gating

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
phosphatidylcholine supplementation
placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia

Eligibility Criteria

1 Week - 7 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

phosphatidylcholine supplementation

placebo supplementation

Arm Description

Phosphatidylcholine supplementation to be administered BID for 8 weeks

Placebo to be administered BID for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of adverse events
Percentage of infants with adverse events

Full Information

First Posted
July 18, 2013
Last Updated
August 31, 2020
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT01905605
Brief Title
Phosphatidylcholine Supplementation in Infants
Official Title
Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not secured. IRB approval has been withdrawn as of January 2017.
Study Start Date
September 2013 (Anticipated)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Diminished P50 Sensory Gating

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phosphatidylcholine supplementation
Arm Type
Experimental
Arm Description
Phosphatidylcholine supplementation to be administered BID for 8 weeks
Arm Title
placebo supplementation
Arm Type
Placebo Comparator
Arm Description
Placebo to be administered BID for 8 weeks
Intervention Type
Drug
Intervention Name(s)
phosphatidylcholine supplementation
Other Intervention Name(s)
Phosphatidylcholine, phosphatidylcholine concentrate
Intervention Description
phosphatidylcholine concentrate 700 mg twice per day
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Corn Oil
Intervention Description
placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day
Primary Outcome Measure Information:
Title
Ratio of P50 auditory sensory gating
Description
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.
Time Frame
8 weeks post initiation of treatment
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Percentage of infants with adverse events
Time Frame
4 weeks and 8 weeks after initiation of intervention
Other Pre-specified Outcome Measures:
Title
Percentage of planned dietary supplement
Description
Percentage of planned dietary supplement given to the infant
Time Frame
8 weeks
Title
Change in serum choline, betaine, and dimethylglycine levels
Time Frame
Randomization and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
7 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Freedman, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ucdenver.edu/academics/colleges/medicalschool/departments/psychiatry/Research/developmentalresearch/Pages/Overview.aspx
Description
University of Colorado School of Medicine Developmental Psychiatry Research Lab

Learn more about this trial

Phosphatidylcholine Supplementation in Infants

We'll reach out to this number within 24 hrs