Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-01 @ 8:04 AM
Study NCT ID:
NCT00789503
Status:
COMPLETED
Last Update Posted:
2008-11-13
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nursing-Home Residents Given Bread Fortified With Vitamin D3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D010018', 'term': 'Osteomalacia'}, {'id': 'D010024', 'term': 'Osteoporosis'}], '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': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002118', 'term': 'Calcium'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-12', 'studyFirstSubmitDate': '2008-11-12', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum 25-hydroxyvitamin D response', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Effects on serum calcium', 'timeFrame': '12 months'}, {'measure': 'Effects on urine calcium', 'timeFrame': '12 months'}, {'measure': 'Change in spine and hip bone mineral density, baseline vs final', 'timeFrame': '12 months'}, {'measure': 'Change in parathyroid hormone, baseline vs final', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dietary fortification', 'Vitamin D3', 'Osteomalacia', 'bread', 'bone mineral density', 'geriatrics', 'cholecalciferol', 'calcidiol', 'osteoporosis', 'dual-energy photon absorptiometry', 'bread fortification'], 'conditions': ['Vitamin D Deficiency', 'Low Bone Density']}, 'referencesModule': {'references': [{'pmid': '24120120', 'type': 'DERIVED', 'citation': 'Mocanu V, Vieth R. Three-year follow-up of serum 25-hydroxyvitamin D, parathyroid hormone, and bone mineral density in nursing home residents who had received 12 months of daily bread fortification with 125 mug of vitamin D(3). Nutr J. 2013 Oct 11;12:137. doi: 10.1186/1475-2891-12-137.'}, {'pmid': '19244376', 'type': 'DERIVED', 'citation': 'Mocanu V, Stitt PA, Costan AR, Voroniuc O, Zbranca E, Luca V, Vieth R. Long-term effects of giving nursing home residents bread fortified with 125 microg (5000 IU) vitamin D(3) per daily serving. Am J Clin Nutr. 2009 Apr;89(4):1132-7. doi: 10.3945/ajcn.2008.26890. Epub 2009 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.\n\nObjective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D3.', 'detailedDescription': 'Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '58 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy seniors in an institution in Romania\n\nExclusion Criteria:\n\n* Known hypercalcemic or hypercalciuric disease'}, 'identificationModule': {'nctId': 'NCT00789503', 'briefTitle': 'Nursing-Home Residents Given Bread Fortified With Vitamin D3', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving', 'orgStudyIdInfo': {'id': 'Bread Vitamin D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bread fortified with vitamin D3 and calcium', 'interventionNames': ['Dietary Supplement: Bread fortified with vitamin D3 and calcium']}], 'interventions': [{'name': 'Bread fortified with vitamin D3 and calcium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Bread fortified with vitamin D3 (5000 IU per bun) and calcium', 'armGroupLabels': ['Bread fortified with vitamin D3 and calcium']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natural Ovens of Manitowoc, Manitowoc, USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr Reinhold Vieth', 'oldOrganization': 'Mount Sinai Hospital, Toronto'}}}}