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

ClinicalTrials.gov processed this record on October 22, 2014