Vitamin D Administration in the Nursing Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204919
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 1, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Osteoporosis Drug: Vitamin D Drug: placebo Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : June 2001
Actual Primary Completion Date : May 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00204919     History of Changes
Other Study ID Numbers: 2001-099
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 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
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents