Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00914810

Last Updated: 2013-06-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

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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Vitamin D

Cholecalciferol (2000 I.U. daily)

Group Type EXPERIMENTAL

Vitamin D (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

2000 I.U. daily for 6 weeks

Placebo

Placebo capsule (sugar pill daily)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (sugar pill) daily for 6 weeks

Interventions

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Vitamin D (cholecalciferol)

2000 I.U. daily for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (sugar pill) daily for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* COPD
* Forced expiratory volume in one second (FEV1) \< or = 50% of predicted
* Smoking history of at least 10 pack-years
* Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)

Exclusion Criteria

* Currently taking \> 500 I.U. per day of vitamin D supplements
* Primary diagnosis of asthma
* Uncompensated heart failure
* Heart attack in the previous 6 months
* Kidney disease (glomerular filtration rate \< 45 mL/min/1.73m2)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Ken M. Kunisaki

Assistant Professor of Medicine and Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ken M. Kunisaki, M.D.

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

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Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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4129-A

Identifier Type: -

Identifier Source: org_study_id

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