Phosphatidylcholine Supplementation in Infants

Schizophrenia Clinical Trial

Official title:

Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01905605
• Other study ID #: 13-2182
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2013
• Est. completion date: January 2017

Study information

• Verified date: August 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diminished P50 Sensory Gating
• Schizophrenia

Intervention

Drug:
• phosphatidylcholine supplementation
phosphatidylcholine concentrate 700 mg twice per day
• placebo
placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of planned dietary supplement	Percentage of planned dietary supplement given to the infant	8 weeks
Other	Change in serum choline, betaine, and dimethylglycine levels		Randomization and 8 weeks
Primary	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	Incidence of adverse events	Percentage of infants with adverse events	4 weeks and 8 weeks after initiation of intervention

External Links

•   University of Colorado School of Medicine Developmental Psychiatry Research Lab