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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Dietary Supplement: Vitamin D (cholecalciferol)
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants from the Minneapolis Veterans Affairs Health Care System were recruited as a convenience sample between January 2009 and October 2011 from outpatient pulmonary clinics and an institutional review board-approved database of patients with COPD.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo : Placebo (sugar pill) daily for 6 weeks
Vitamin D Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks

Participant Flow:   Overall Study
    Placebo   Vitamin D
STARTED   20   19 
COMPLETED   18   18 
NOT COMPLETED   2   1 
Withdrawal by Subject                1                0 
Relocated out of state                1                0 
Hospitalized and unable to follow up.                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo : Placebo (sugar pill) daily for 6 weeks
Vitamin D Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Vitamin D   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   39 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   68  (8)   67.6  (7)   68  (8) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   20   19   39 
Region of Enrollment 
[Units: Participants]
     
United States   20   19   39 


  Outcome Measures

1.  Primary:   Change in Short Physical Performance Battery (SPPB) Score   [ Time Frame: Baseline and 6 weeks ]

2.  Secondary:   Change in Blood Level of Vitamin D (25-hydroxyvitamin D)   [ Time Frame: Baseline and 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ken Kunisaki, M.D.
Organization: Minneapolis VA Health Care System
phone: 612-467-4400
e-mail: kunis001@umn.edu



Responsible Party: Ken M. Kunisaki, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00914810     History of Changes
Other Study ID Numbers: 4129-A
First Submitted: June 4, 2009
First Posted: June 5, 2009
Results First Submitted: April 22, 2013
Results First Posted: June 11, 2013
Last Update Posted: June 11, 2013