Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- NCT00914810
- Lead Sponsor
- Minneapolis Veterans Affairs Medical Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Short Physical Performance Battery (SPPB) Score Baseline and 6 weeks 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
Name Time Method Change in Blood Level of Vitamin D (25-hydroxyvitamin D) Baseline and 6 weeks
Trial Locations
- Locations (1)
Minneapolis VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
Minneapolis VA Medical Center🇺🇸Minneapolis, Minnesota, United States