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

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D (cholecalciferol)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00914810

4129-A

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

Cholecalciferol (2000 I.U. daily)

Treatment:

Dietary Supplement: Vitamin D (cholecalciferol)

Placebo

Placebo Comparator group

Description:

Placebo capsule (sugar pill daily)

Treatment:

Dietary Supplement: Placebo