Study Stopped
Funding not secured. IRB approval has been withdrawn as of January 2017.
Phosphatidylcholine Supplementation in Infants
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2013
Longer than P75 for phase_1 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2013
CompletedFirst Posted
Study publicly available on registry
July 23, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedSeptember 2, 2020
August 1, 2020
3.3 years
July 18, 2013
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of adverse events
4 weeks and 8 weeks after initiation of intervention
Other Outcomes (2)
Percentage of planned dietary supplement
8 weeks
Change in serum choline, betaine, and dimethylglycine levels
Randomization and 8 weeks
Study Arms (2)
phosphatidylcholine supplementation
EXPERIMENTALPhosphatidylcholine supplementation to be administered BID for 8 weeks
placebo supplementation
PLACEBO COMPARATORPlacebo to be administered BID for 8 weeks
Interventions
phosphatidylcholine concentrate 700 mg twice per day
placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Freedman, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2013
First Posted
July 23, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
September 2, 2020
Record last verified: 2020-08