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Funding not secured. IRB approval has been withdrawn as of January 2017.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phosphatidylcholine supplementation | Experimental | Phosphatidylcholine supplementation to be administered BID for 8 weeks |
|
| placebo supplementation | Placebo Comparator | Placebo to be administered BID for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phosphatidylcholine supplementation | Drug | phosphatidylcholine concentrate 700 mg twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Percentage of infants with adverse events | 4 weeks and 8 weeks after initiation of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of planned dietary supplement | Percentage of planned dietary supplement given to the infant | 8 weeks |
| Change in serum choline, betaine, and dimethylglycine levels | Randomization and 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Freedman, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| University of Colorado School of Medicine Developmental Psychiatry Research Lab | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010713 | Phosphatidylcholines |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
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| placebo | Drug | placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day |
|
|
| D008563 |
| Membrane Lipids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |