Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin D (cholecalciferol)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic obstructive pulmonary disease, Vitamin D, Cholecalciferol, Skeletal muscle
Eligibility Criteria
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)
Sites / Locations
- Minneapolis VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Cholecalciferol (2000 I.U. daily)
Placebo capsule (sugar pill daily)
Outcomes
Primary Outcome Measures
Change in Short Physical Performance Battery (SPPB) Score
SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.
Secondary Outcome Measures
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Full Information
NCT ID
NCT00914810
First Posted
June 4, 2009
Last Updated
June 7, 2013
Sponsor
Minneapolis Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00914810
Brief Title
Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic obstructive pulmonary disease, Vitamin D, Cholecalciferol, Skeletal muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Cholecalciferol (2000 I.U. daily)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule (sugar pill daily)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (cholecalciferol)
Intervention Description
2000 I.U. daily for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (sugar pill) daily for 6 weeks
Primary Outcome Measure Information:
Title
Change in Short Physical Performance Battery (SPPB) Score
Description
SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken M. Kunisaki, M.D.
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
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