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

NCT00914810 | Completed Phase 3 Results

• 1 other identifier: 4129-A
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease; Vitamin D; Cholecalciferol; Skeletal muscle

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery (SPPB) Score

  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.

  Baseline and 6 weeks

Secondary Outcomes (1)

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

  Baseline and 6 weeks

Study Arms (2)

Vitamin D

EXPERIMENTAL

Cholecalciferol (2000 I.U. daily)

Dietary Supplement: Vitamin D (cholecalciferol)

Placebo

PLACEBO COMPARATOR

Placebo capsule (sugar pill daily)

Dietary Supplement: Placebo

Interventions

Vitamin D (cholecalciferol) DIETARY_SUPPLEMENT

2000 I.U. daily for 6 weeks

Vitamin D

Placebo DIETARY_SUPPLEMENT

Placebo (sugar pill) daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Ken Kunisaki, M.D.
• Organization: Minneapolis VA Health Care System

kunis001@umn.edu

612-467-4400

Study Officials

• Ken M. Kunisaki, M.D.

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Staff Physician

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 11, 2013
• Results First Posted: June 11, 2013

Record last verified: 2013-06

Locations

US (1)