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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00524 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 240913 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source | |
| P50CA090440 | U.S. NIH Grant/Contract | View source |
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low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with COPD.
PRIMARY OBJECTIVES:
I. To establish the effect of D vitamin (vitamin D3) supplementation on inspiratory muscle strength in vitamin D3-deficient chronic obstructive pulmonary disease (COPD) patients. (Roswell Park Cancer Institute [RPCI]/University at Buffalo [UB] study) II. To establish the 12 month conversion rate. (University of Pittsburgh Cancer Institute [UPCI] study)
SECONDARY OBJECTIVES:
I. To establish the effect of vitamin D3 supplementation on peripheral muscle strength and exercise capacity in vitamin D3-deficient COPD patients. (RPCI/UB study) II. To establish the 3 and 6-month conversion rates. (UPCI study) III. To examine whether vitamin D3 supplementation is equally effective in COPD patients who are current versus former smokers. (UPCI study)
TERTIARY OBJECTIVES:
I. To explore the effects of vitamin D3 supplementation in COPD patients on biomarkers of lung cancer risk, inflammation, and pulmonary function. (UPCI study)
OUTLINE: Patients are randomized to 1 of 2 arms.
CONTROL ARM: Patients receive a placebo and multivitamin orally (PO) once daily (QD) for 52 weeks.
SUPPLEMENTATION ARM: Patients receive a multivitamin and cholecalciferol supplement PO QD for 52 weeks.
After completion of study treatment, patients are followed up for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm (multivitamin, placebo) | Active Comparator | Patients receive a placebo and multivitamin orally each day for 52 weeks. |
|
| Supplementation arm (multivitamin, cholecalciferol) | Experimental | Patients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study) | 75% will be considered a success. | At 12 months |
| Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study) | Will be analyzed using linear mixed model by regressing the repeated outcome on the group indicator (treatment or control) and other appropriate covariates. Appropriate within-subject covariance will be determined from an exploratory study. The effect of vitamin D3 supplementation will be tested using an approximate t-test. | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study) | Peak oxygen consumption will be used to establish cardiovascular fitness. Breath-by-breath measurements of minute ventilation, tidal volume, breathing frequency, end tidal carbon dioxide, carbon dioxide production and oxygen consumption will be continuously measured. | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in correlative biomarkers of lung cancer risk, inflammation, and pulmonary function (UPCI study) | The vitamin D3 supplementation group will be compared to the placebo control group using two-sample t-tests at each time point for preliminary analysis. The correlation between muscle strength and the correlative biomarkers will be explored using Pearson correlation. | Baseline to up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Mahoney | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Multivitamin | Dietary Supplement | Given PO |
|
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| Placebo | Other | Given PO |
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| Questionnaire Administration | Other | Ancillary studies |
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| Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study) | The elbow flexion test (upper extremity) requires participants to curl a standard 8 lb weight as many times as possible in a 30 second time period. | Baseline to 24 weeks |
| Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study) | Efficacy in in COPD patients who are current versus former smokers will be compared. | At 3 months |
| Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study) | Efficacy in in COPD patients who are current versus former smokers will be compared. | At 6 months |
| Change in peripheral muscle strength assessed by squat test (RPCI/UB study) | This functional sit-to-stand test measures lower extremity strength. Participants will perform as many sit-to-stand repetitions from a standard height chair in 60 seconds as possible. | Baseline to 24 weeks |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D018908 | Muscle Weakness |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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