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Vitamin D Administration in the Nursing Home

Primary Purpose

Vitamin D Deficiency, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
placebo
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring osteoporosis, vitamin D deficiency

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or Female Nursing Home Resident in Wisconsin Exclusion Criteria: Renal Failure Hypercalcemia Metastatic Cancer

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Plasma 25-hydroxyvitamin D levels

Secondary Outcome Measures

Plasma calcium

Full Information

First Posted
September 13, 2005
Last Updated
October 2, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00204919
Brief Title
Vitamin D Administration in the Nursing Home
Official Title
Intermittent Vitamin D Administration in the Nursing Home: Impact on Vitamin D Status, Falls, Bone Turnover and Bone Density
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Osteoporosis
Keywords
osteoporosis, vitamin D deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
ergocalciferol
Intervention Description
once-monthly vitamin D oral capsules (50,000 units)
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
lactose
Intervention Description
once-monthly placebo capsules
Primary Outcome Measure Information:
Title
Plasma 25-hydroxyvitamin D levels
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Plasma calcium
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female Nursing Home Resident in Wisconsin Exclusion Criteria: Renal Failure Hypercalcemia Metastatic Cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Elliott, PharmD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Vitamin D Administration in the Nursing Home

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