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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma calcium [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or Female
  • Nursing Home Resident in Wisconsin

Exclusion Criteria:

  • Renal Failure
  • Hypercalcemia
  • Metastatic Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: United States: Food and Drug Administration

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 October 21, 2016