Vitamin D Administration in the Nursing Home

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204919
First received: September 13, 2005
Last updated: July 10, 2008
Last verified: July 2008
  Purpose

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
Osteoporosis
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).

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female
  • Nursing Home Resident in Wisconsin

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Mary Beth Elliott, PharmD, PhD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00204919     History of Changes
Other Study ID Numbers: 2001-099
Study First Received: September 13, 2005
Last Updated: July 10, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Osteoporosis
Vitamin D Deficiency
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 14, 2014