Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014