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)
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D (cholecalciferol)

• 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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2013-04-22
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-07
• Last Update Submitted: 2013-06-07
• Results First Posted: 2013-06-11
• Last Update Posted: 2013-06-11

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule (sugar pill daily)
Vitamin D	Vitamin D (cholecalciferol)	Cholecalciferol (2000 I.U. daily)

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