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Vitamin D Administration in the Nursing Home

Not Applicable
Completed
Conditions
Osteoporosis
Vitamin D Deficiency
Interventions
Drug: placebo
Registration Number
NCT00204919
Lead Sponsor
University of Wisconsin, Madison
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
96
Inclusion Criteria
  • Male or Female
  • Nursing Home Resident in Wisconsin
Exclusion Criteria
  • Renal Failure
  • Hypercalcemia
  • Metastatic Cancer

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1placebo-
2Vitamin D-
Primary Outcome Measures
NameTimeMethod
Plasma 25-hydroxyvitamin D levels1 year
Secondary Outcome Measures
NameTimeMethod
Plasma calciumone year

Trial Locations

Locations (1)

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

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