Phosphatidylcholine Supplementation in Infants

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Schizophrenia; Diminished P50 Sensory Gating

Treatments: Drug: phosphatidylcholine supplementation; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01905605

13-2182

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 7 weeks old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

phosphatidylcholine supplementation

Experimental group

Description:

Phosphatidylcholine supplementation to be administered BID for 8 weeks

Treatment:

Drug: phosphatidylcholine supplementation

placebo supplementation

Placebo Comparator group

Description:

Placebo to be administered BID for 8 weeks

Treatment:

Drug: placebo