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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00914810
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Dietary Supplement: Vitamin D (cholecalciferol) Dietary Supplement: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.
Study Start Date : June 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vitamin D
Cholecalciferol (2000 I.U. daily)
Dietary Supplement: Vitamin D (cholecalciferol)
2000 I.U. daily for 6 weeks
Placebo Comparator: Placebo
Placebo capsule (sugar pill daily)
Dietary Supplement: Placebo
Placebo (sugar pill) daily for 6 weeks

Outcome Measures

Primary Outcome Measures :
  1. Change in Short Physical Performance Battery (SPPB) Score [ Time Frame: 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 :
  1. Change in Blood Level of Vitamin D (25-hydroxyvitamin D) [ Time Frame: Baseline and 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914810

United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Principal Investigator: Ken M. Kunisaki, M.D. Minneapolis Veterans Affairs Medical Center
More Information

Responsible Party: Ken M. Kunisaki, Assistant Professor of Medicine and Staff Physician, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00914810     History of Changes
Other Study ID Numbers: 4129-A
First Posted: June 5, 2009    Key Record Dates
Results First Posted: June 11, 2013
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by Ken M. Kunisaki, Minneapolis Veterans Affairs Medical Center:
Chronic obstructive pulmonary disease
Vitamin D
Skeletal muscle

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents