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Vitamin D Administration in the Nursing Home

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00204919
Enrollment
96
Registered
2005-09-20
Start date
2001-06-30
Completion date
2004-11-30
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Vitamin D Deficiency

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

DRUGVitamin D

once-monthly vitamin D oral capsules (50,000 units)

DRUGplacebo

once-monthly placebo capsules

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or Female * Nursing Home Resident in Wisconsin

Exclusion criteria

* Renal Failure * Hypercalcemia * Metastatic Cancer

Design outcomes

Primary

MeasureTime frame
Plasma 25-hydroxyvitamin D levels1 year

Secondary

MeasureTime frame
Plasma calciumone year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026