Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic obstructive pulmonary disease, Vitamin D, Cholecalciferol, Skeletal muscle
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).
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo (sugar pill) daily for 6 weeks
DIETARY_SUPPLEMENTVitamin D (cholecalciferol)
2000 I.U. daily for 6 weeks
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | Baseline and 6 weeks |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo : Placebo (sugar pill) daily for 6 weeks | 20 |
| Vitamin D Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Hospitalized and unable to follow up. | 0 | 1 |
| Overall Study | Relocated out of state | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Vitamin D | Total |
|---|---|---|---|
| Age Continuous Age | 68 years STANDARD_DEVIATION 8 | 67.6 years STANDARD_DEVIATION 7 | 68 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 20 participants | 19 participants | 39 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
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.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Short Physical Performance Battery (SPPB) Score | 0.6 units on a scale | Standard Deviation 1.7 |
| Vitamin D | Change in Short Physical Performance Battery (SPPB) Score | 0.9 units on a scale | Standard Deviation 1.6 |
p-value: 0.5595% CI: [-0.8, 1.5]t-test, 2 sided
Secondary
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Time frame: Baseline and 6 weeks
Population: 25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | -1.8 ng/mL | Standard Deviation 3.1 |
| Vitamin D | Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | 8.7 ng/mL | Standard Deviation 5.5 |
p-value: <0.000195% CI: [7.4, 13.6]t-test, 2 sided