Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-11 @ 1:08 PM
Study NCT ID:
NCT01905605
Status:
WITHDRAWN
Last Update Posted:
2020-09-02
First Post:
2013-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phosphatidylcholine Supplementation in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010713', 'term': 'Phosphatidylcholines'}, {'id': 'D003314', 'term': 'Corn Oil'}], 'ancestors': [{'id': 'D020404', 'term': 'Glycerophospholipids'}, {'id': 'D010712', 'term': 'Phosphatidic Acids'}, {'id': 'D005994', 'term': 'Glycerophosphates'}, {'id': 'D010743', 'term': 'Phospholipids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding not secured. IRB approval has been withdrawn as of January 2017.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2013-07-18', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of planned dietary supplement', 'timeFrame': '8 weeks', 'description': 'Percentage of planned dietary supplement given to the infant'}, {'measure': 'Change in serum choline, betaine, and dimethylglycine levels', 'timeFrame': 'Randomization and 8 weeks'}], 'primaryOutcomes': [{'measure': 'Ratio of P50 auditory sensory gating', 'timeFrame': '8 weeks post initiation of treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '4 weeks and 8 weeks after initiation of intervention', 'description': 'Percentage of infants with adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Diminished P50 Sensory Gating']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Weeks', 'minimumAge': '1 Week', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks\n* Diminished P50 sensory gating (ratio greater than or equal to 0.50)\n\nExclusion Criteria:\n\n* No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)\n* Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use'}, 'identificationModule': {'nctId': 'NCT01905605', 'briefTitle': 'Phosphatidylcholine Supplementation in Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating', 'orgStudyIdInfo': {'id': '13-2182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'phosphatidylcholine supplementation', 'description': 'Phosphatidylcholine supplementation to be administered BID for 8 weeks', 'interventionNames': ['Drug: phosphatidylcholine supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo supplementation', 'description': 'Placebo to be administered BID for 8 weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'phosphatidylcholine supplementation', 'type': 'DRUG', 'otherNames': ['Phosphatidylcholine, phosphatidylcholine concentrate'], 'description': 'phosphatidylcholine concentrate 700 mg twice per day', 'armGroupLabels': ['phosphatidylcholine supplementation']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Corn Oil'], 'description': 'placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day', 'armGroupLabels': ['placebo supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Robert Freedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}