Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-30 @ 1:19 PM
Study NCT ID:
NCT00494104
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2007-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Vitamin D Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2007-06-28', 'studyFirstSubmitQcDate': '2007-06-28', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase', 'timeFrame': 'end of winter'}], 'secondaryOutcomes': [{'measure': 'whole body mineral content by DEXA', 'timeFrame': 'end of winter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin D deficiency', 'breastfed infant', 'northern latitude', 'infant', 'breastfed', 'winter', 'vitamin D status'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '24858141', 'type': 'DERIVED', 'citation': 'Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatr Res. 2014 Aug;76(2):177-83. doi: 10.1038/pr.2014.76. Epub 2014 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency', 'detailedDescription': 'It is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin D deficiency, especially if their skin is darkly pigmented. The study by the PI (Pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin D deficiency. During winter (December - April) a full 78% of infants were vitamin D deficient if they did not receive vitamin D from an external source. Very few breastfed babies are currently receiving supplemental vitamin D. The recommended dose is 200 IU/day. However, there are questions about the adequacy of this dose of vitamin D for the prevention of vitamin D deficiency. The present trial is designed to determine whether a dose of 200 IU/day is effective or whether doses of 400 IU/day, 600 IU/day or 800 IU/day are required to prevent vitamin D deficiency reliably.\n\nThe trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or 600 IU/day or 800 IU/day from 1 to 9 months of age. There will not be a placebo control group. Infants will be followed through 12 months of age. Normal term infants (birth weight \\>2500 g) who are born in June through November will be enrolled and randomized at 1 month of age. They will visit the study center at monthly intervals and will have capillary blood drawn at select ages. At 2 months and again in March or April whole body mineral content will be determined by DEXA. Infants will not be permitted to receive formula until 9 months of age. They may receive complementary foods beginning at 4 months of age. Vitamin D supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. Study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between March and May 15. Blood parameters include 25-OHD, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, N-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Weeks', 'minimumAge': '3 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term infant\n* No major congenital malformations\n* Less than one month old\n* Breastfed, no other foods\n\nExclusion Criteria:\n\n* Formula feeding\n* Premature birth'}, 'identificationModule': {'nctId': 'NCT00494104', 'briefTitle': 'Prevention of Vitamin D Deficiency', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Prevention of Vitamin D Deficiency in Breastfed Infants', 'orgStudyIdInfo': {'id': 'R01HD048870', 'link': 'https://reporter.nih.gov/quickSearch/R01HD048870', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HD048870', 'link': 'https://reporter.nih.gov/quickSearch/R01HD048870', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '200 IU/day Vitamin D', 'description': '200 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day']}, {'type': 'EXPERIMENTAL', 'label': '400 IU/day Vitamin D', 'description': '400 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day']}, {'type': 'EXPERIMENTAL', 'label': '600 IU/day Vitamin D', 'description': '600 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day']}, {'type': 'EXPERIMENTAL', 'label': '800 IU/day Vitamin D', 'description': '800 IU/day Vitamin D', 'interventionNames': ['Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day']}], 'interventions': [{'name': 'Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants receive daily 0.5 ml of code labeled supplement', 'armGroupLabels': ['200 IU/day Vitamin D', '400 IU/day Vitamin D', '600 IU/day Vitamin D', '800 IU/day Vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52241-8802', 'city': 'Coralville', 'state': 'Iowa', 'country': 'United States', 'facility': 'MTF, 2501 Crosspark Rd', 'geoPoint': {'lat': 41.6764, 'lon': -91.58045}}], 'overallOfficials': [{'name': 'Ekhard Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}