| January 2, 2008 |
| June 5, 2008 |
| February 2007 |
| November 2008 (final data collection date for primary outcome measure) |
| The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00692120 on ClinicalTrials.gov Archive Site |
- Determine whether once monthly vitamin D2 or D3 dosing is as effective as daily dosing in attainment, and subsequent maintenance, of 25OHD status [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Delineate the effect of these vitamin D regimens on other parameters of skeletal relevance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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| Same as current |
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| Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy |
| Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy |
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. |
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| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
- Vitamin D Inadequacy
- Vitamin D Deficiency
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- Dietary Supplement: Cholecalciferol (vitamin D3)
- Dietary Supplement: Ergocalciferol (vitamin D2)
- Dietary Supplement: Placebo
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| Active, not recruiting |
| 64 |
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| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Community dwelling men and women age ≥ 65 years.
- Able and willing to sign informed consent.
- Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.
- 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
Exclusion Criteria:
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- History of nephrolithiasis.
- Screening 25OHD concentration ≥ 60 ng/ml.
- Baseline 24-hour urine calcium > 250 mg if female, > 300 mg if male.
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease
- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer.
- Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute
- Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study
- Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc.
- Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin
- Vitamin D intake greater than 5,000 IU daily
- Treatment with any active metabolites of vitamin D within six months of screening
- Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.
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| Both |
| 65 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00692120 |
| Neil Binkley, MD, University of Wisconsin - Institute on Aging |
| 2006-0013 |
| University of Wisconsin, Madison |
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| Principal Investigator: |
Neil Binkley, MD |
University of Wisconsin - Institute on Aging |
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| University of Wisconsin, Madison |
| June 2008 |