Osteoporosis, Vitamin D Deficiency
Conditions
Keywords
osteoporosis, vitamin D deficiency
Brief summary
Administration of vitamin D 50,000 units once monthly will: * Maintain serum 25-OH vitamin D above 20 ng/ml * Reduce falls * Increase calcaneal BMD * Reduce bone turnover * Be well tolerated: volunteers will not develop hypercalcemia * Improve performance on a swallowing quality of life questionnaire
Detailed description
1\. Research questions: We propose a prospective double-blind, randomized, placebo-controlled trial of once-monthly vitamin D oral capsules (50,000 units) in nursing-home residents. Subjects from several Wisconsin nursing homes were randomized to receive once-monthly vitamin D oral capsules (50,000 units) or placebo. Blood levels of 25-OH D, parathyroid hormone, serum calcium, and a marker of bone turnover will be measured periodically by standard lab assays. Swallowing quality of life was measured by questionnaire. Appropriate statistical tests (paired T tests, 95% confidence intervals will be calculated with the large sample approximation for binomial variables, other).
Interventions
once-monthly vitamin D oral capsules (50,000 units)
once-monthly placebo capsules
Sponsors
Study design
Eligibility
Inclusion criteria
* Male or Female * Nursing Home Resident in Wisconsin
Exclusion criteria
* Renal Failure * Hypercalcemia * Metastatic Cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma 25-hydroxyvitamin D levels | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Plasma calcium | one year |
Countries
United States