Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00692120
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2008-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D004872', 'term': 'Ergocalciferols'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status', 'timeFrame': '12 months'}, {'measure': 'Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vitamin D Inadequacy', 'Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '21289249', 'type': 'DERIVED', 'citation': 'Binkley N, Gemar D, Engelke J, Gangnon R, Ramamurthy R, Krueger D, Drezner MK. Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. J Clin Endocrinol Metab. 2011 Apr;96(4):981-8. doi: 10.1210/jc.2010-0015. Epub 2011 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Community dwelling men and women age ≥ 65 years.\n2. Able and willing to sign informed consent.\n3. Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.\n4. Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed\n\nExclusion Criteria:\n\n1. Current hypercalcemia (serum calcium \\> 10.5 mg/dl) or untreated primary hyperparathyroidism.\n2. History of nephrolithiasis.\n3. Screening 25OHD concentration ≥ 60 ng/ml.\n4. Baseline 24-hour urine calcium \\> 250 mg if female, \\> 300 mg if male.\n5. Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease\n6. History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer.\n7. Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute\n8. Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study\n9. Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc.\n10. Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin\n11. Vitamin D intake greater than 5,000 IU daily\n12. Treatment with any active metabolites of vitamin D within six months of screening\n13. Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin."}, 'identificationModule': {'nctId': 'NCT00692120', 'acronym': 'D2/D3', 'briefTitle': 'Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy', 'orgStudyIdInfo': {'id': '2006-0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: Ergocalciferol (vitamin D2)', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Dietary Supplement: Ergocalciferol (vitamin D2)', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Dietary Supplement: Cholecalciferol (vitamin D3)', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Dietary Supplement: Cholecalciferol (vitamin D3)', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Cholecalciferol (vitamin D3)', 'type': 'DIETARY_SUPPLEMENT', 'description': '50,000 IU once monthly for 12 months', 'armGroupLabels': ['3']}, {'name': 'Ergocalciferol (vitamin D2)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral capsule 50,000 IU once monthly for 12 months', 'armGroupLabels': ['1']}, {'name': 'Ergocalciferol (vitamin D2)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral capsule 1600 IU once daily for 12 months', 'armGroupLabels': ['2']}, {'name': 'Cholecalciferol (vitamin D3)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral capsule 1600 IU once daily for 12 months', 'armGroupLabels': ['4']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral placebo capsule once daily for 12 months', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Osteoporosis Clinical and Research Program', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Neil Binkley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin - Institute on Aging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}