Vitamin D Administration in the Nursing Home

NCT ID: NCT00204919

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2004-11-30

Brief Summary

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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

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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).

Conditions

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Vitamin D Deficiency Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

once-monthly placebo capsules

2

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

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

Interventions

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Vitamin D

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

Intervention Type DRUG

placebo

once-monthly placebo capsules

Intervention Type DRUG

Other Intervention Names

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ergocalciferol lactose

Eligibility Criteria

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Inclusion Criteria

* Male or Female
* Nursing Home Resident in Wisconsin

Exclusion Criteria

* Renal Failure
* Hypercalcemia
* Metastatic Cancer
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Elliott, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2001-099

Identifier Type: -

Identifier Source: org_study_id

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