Vitamin D Administration in the Nursing Home

University of Wisconsin (UW)

Status: Completed

Conditions: Osteoporosis; Vitamin D Deficiency

Treatments: Drug: placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00204919

2001-099

Details and patient eligibility

About

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

Full 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).

Enrollment: 96 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female
• Nursing Home Resident in Wisconsin

Exclusion criteria

• Renal Failure
• Hypercalcemia
• Metastatic Cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Active Comparator group

Treatment:

Drug: Vitamin D