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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
Enrollment 39
Recruitment Details 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  
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Placebo : Placebo (sugar pill) daily for 6 weeks Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Period Title: Overall Study
Started 20 19
Completed 18 18
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             0
Relocated out of state             1             0
Hospitalized and unable to follow up.             0             1
Arm/Group Title Placebo Vitamin D Total
Hide Arm/Group Description Placebo : Placebo (sugar pill) daily for 6 weeks Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 20 participants 19 participants 39 participants
68  (8) 67.6  (7) 68  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
19
 100.0%
39
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 39 participants
20 19 39
1.Primary Outcome
Title Change in Short Physical Performance Battery (SPPB) Score
Hide Description 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.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
Placebo : Placebo (sugar pill) daily for 6 weeks
Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.7) 0.9  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.8 to 1.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Hide Description [Not Specified]
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
Placebo : Placebo (sugar pill) daily for 6 weeks
Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: ng/mL
-1.8  (3.1) 8.7  (5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.5
Confidence Interval (2-Sided) 95%
7.4 to 13.6
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Placebo : Placebo (sugar pill) daily for 6 weeks Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
All-Cause Mortality
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
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
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