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

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ClinicalTrials.gov Identifier: NCT00914810
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
Ken M. Kunisaki, 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).

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

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
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


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




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 ]


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

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


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

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
Cholecalciferol
Skeletal muscle

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