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Completed

NCT Number: NCT00914810

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D (cholecalciferol)

Dietary Supplement

2000 I.U. daily for 6 weeks

Placebo

Dietary Supplement

Placebo (sugar pill) daily for 6 weeks

Primary outcomes

  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 outcomes

  1. Change in Blood Level of Vitamin D (25-hydroxyvitamin D)

    Time frame: Baseline and 6 weeks

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Official study title

Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 5, 2009
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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