Skip to main content
OpenTrials
Completed

NCT Number: NCT00204919

Vitamin D Administration in the Nursing Home

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Bone Diseases Bone Diseases, Metabolic Deficiency Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female
  • Nursing Home Resident in Wisconsin

Exclusion criteria

  • Renal Failure
  • Hypercalcemia
  • Metastatic Cancer

Treatment and study plan

Vitamin D

Drug

once-monthly vitamin D oral capsules (50,000 units)

Other names: ergocalciferol

Placebo

Drug

once-monthly placebo capsules

Other names: lactose

Primary outcomes

  1. Plasma 25-hydroxyvitamin D levels

    Time frame: 1 year

Secondary outcomes

  1. Plasma calcium

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Intermittent Vitamin D Administration in the Nursing Home: Impact on Vitamin D Status, Falls, Bone Turnover and Bone Density

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.