Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2001-06-30
2004-11-30
Brief Summary
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* 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
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
placebo
once-monthly placebo capsules
2
Vitamin D
once-monthly vitamin D oral capsules (50,000 units)
Interventions
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Vitamin D
once-monthly vitamin D oral capsules (50,000 units)
placebo
once-monthly placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nursing Home Resident in Wisconsin
Exclusion Criteria
* Hypercalcemia
* Metastatic Cancer
55 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Mary Elliott, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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2001-099
Identifier Type: -
Identifier Source: org_study_id
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