Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 4:41 PM
Study NCT ID:
NCT01803659
Status:
COMPLETED
Last Update Posted:
2015-06-11
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Small Daily Doses of B-carotene on Breast Milk Retinol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019207', 'term': 'beta Carotene'}, {'id': 'C014794', 'term': 'retinol palmitate'}], 'ancestors': [{'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-03-01', 'lastUpdatePostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'breast milk retinol concentration', 'timeFrame': '3 weeks', 'description': 'breast milk retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d'}], 'secondaryOutcomes': [{'measure': 'plasma retinol concentration', 'timeFrame': '3 weeks', 'description': 'plasma retinol concentration is measured at baseline and after 3 weeks of supplementation with 600 ug RAE/d (as either b-carotene or retinyl palmitate) or 0 ug RAE/d'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['b-carotene', 'breastmilk', 'vitamin A'], 'conditions': ['Vitamin A Status']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine whether breast milk retinol concentration increases in response to daily supplementation with small amounts of vitamin A (\\~600 ug RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary purpose is to evaluate sampling methods for collecting breast milk samples in a community setting. The results of this pilot study will allow us to determine whether milk retinol is a useful indicator for evaluating the impact of food-based interventions on the vitamin A status of lactating women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lactating women breastfeeding a single infant 4-12 months of age\n\nExclusion Criteria:\n\n* chronic disease\n* breastfeeding more than one infant\n* severe anemia\n* signs or symptoms of vitamin A deficiency'}, 'identificationModule': {'nctId': 'NCT01803659', 'briefTitle': 'Effect of Small Daily Doses of B-carotene on Breast Milk Retinol', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effect of Small Daily Doses of B-carotene or Vitamin A on Breast Milk Retinol Concentration in Lactating Filipino Women.', 'orgStudyIdInfo': {'id': '6195-2012-01-00-HKI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'b-carotene', 'description': '600 ug RAE/d as b-carotene, 6 d/wk for 3 weeks', 'interventionNames': ['Dietary Supplement: b-carotene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'retinyl palmitate', 'description': '600 ug retinol equivalent/d, 6 d/wk for 3 weeks', 'interventionNames': ['Dietary Supplement: retinyl palmitate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (corn oil)', 'description': '0 ug RAE/d as corn oil', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'b-carotene', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['b-carotene']}, {'name': 'retinyl palmitate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['retinyl palmitate']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placebo (corn oil)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helen Keller International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}