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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ken M. Kunisaki, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00914810
First received: June 4, 2009
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Dietary Supplement: Vitamin D (cholecalciferol)
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in Short Physical Performance Battery (SPPB) Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in Blood Level of Vitamin D (25-hydroxyvitamin D) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 4, 2009
Results First Received: April 22, 2013
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Chronic obstructive pulmonary disease
Vitamin D
Cholecalciferol
Skeletal muscle

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

ClinicalTrials.gov processed this record on April 17, 2014