Status:
COMPLETED
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Vitamin D Inadequacy
Vitamin D Deficiency
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00692120
Start Date
February 1 2007
End Date
November 1 2008
Last Update
October 5 2015
Active Locations (1)
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1
UW Osteoporosis Clinical and Research Program
Madison, Wisconsin, United States, 53705