Phosphatidylcholine Supplementation in Infants

• Status: Withdrawn
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver

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