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

• Sponsor: Minneapolis Veterans Affairs Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00914810
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Dietary Supplement: Vitamin D (cholecalciferol); Dietary Supplement: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in Short Physical Performance Battery (SPPB) Score [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 Outcome Measures

1. Change in Blood Level of Vitamin D (25-hydroxyvitamin D) [Baseline and 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ken M. Kunisaki, Assistant Professor of Medicine and Staff Physician, Minneapolis Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT00914810
• Other Study ID Numbers: 4129-A
• First Posted: Jun 5, 2009
• Last Update Posted: Jun 11, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Ken M. Kunisaki, Assistant Professor of Medicine and Staff Physician, 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; Vitamin D; Cholecalciferol

Study Results

Participant Flow

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.

Arm/Group Title	Placebo	Vitamin D
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

Baseline Characteristics

Arm/Group Title	Placebo	Vitamin D	Total
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 Participants	20	19	39
Age (years) [Mean (Standard Deviation) ]
Age	68 (8)	67.6 (7)	68 (8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	20 100%	19 100%	39 100%
Region of Enrollment (participants) [Number]
United States	20 100%	19 100%	39 100%

Outcome Measures

1. Primary Outcome

Title	Change in Short Physical Performance Battery (SPPB) Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Vitamin D
Arm/Group Description	Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Measure Participants	18	18
Mean (Standard Deviation) [units on a scale]	0.6 (1.7)	0.9 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vitamin D
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -0.8 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Time Frame	Baseline and 6 weeks

Outcome Measure Data

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
Arm/Group Description	Placebo : Placebo (sugar pill) daily for 6 weeks	Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
Measure Participants	18	16
Mean (Standard Deviation) [ng/mL]	-1.8 (3.1)	8.7 (5.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Vitamin D
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.5
	Confidence Interval	(2-Sided) 95%; 7.4 to 13.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Placebo		Vitamin D
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Vitamin D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Vitamin D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.