Vitamin D Administration in the Nursing Home

Osteoporosis Clinical Trial

Official title:

Intermittent Vitamin D Administration in the Nursing Home: Impact on Vitamin D Status, Falls, Bone Turnover and Bone Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204919
• Other study ID #: 2001-099
• Status: Completed
• Phase: N/A
• Start date: June 2001
• Est. completion date: November 2004

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Male or Female

• Nursing Home Resident in Wisconsin

Exclusion Criteria:

• Renal Failure

• Hypercalcemia

• Metastatic Cancer

Related Conditions & MeSH terms

• Osteoporosis
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
once-monthly vitamin D oral capsules (50,000 units)
• placebo
once-monthly placebo capsules

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma 25-hydroxyvitamin D levels		1 year
Secondary	Plasma calcium		one year