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Vitamin D Administration in the Nursing Home

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: September 30, 2015
Last verified: September 2015

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

Condition Intervention
Vitamin D Deficiency
Drug: Vitamin D
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Vitamin D Administration in the Nursing Home: Impact on Vitamin D Status, Falls, Bone Turnover and Bone Density

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Plasma 25-hydroxyvitamin D levels [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Plasma calcium [ Time Frame: one year ]

Enrollment: 96
Study Start Date: June 2001
Study Completion Date: November 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
once-monthly placebo capsules
Other Name: lactose
Active Comparator: 2 Drug: Vitamin D
once-monthly vitamin D oral capsules (50,000 units)
Other Name: ergocalciferol

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).


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or Female
  • Nursing Home Resident in Wisconsin

Exclusion Criteria:

  • Renal Failure
  • Hypercalcemia
  • Metastatic Cancer
  Contacts and Locations
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Please refer to this study by its identifier: NCT00204919

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Mary Elliott, PharmD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00204919     History of Changes
Other Study ID Numbers: 2001-099
Study First Received: September 13, 2005
Last Updated: September 30, 2015

Keywords provided by University of Wisconsin, Madison:
vitamin D deficiency

Additional relevant MeSH terms:
Vitamin D Deficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017