- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02877641
Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease
Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current or ex-smoker with at least a 10-year pack history
- COPD, defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% and FEV1% predicted < 80%
- 25-hydroxy vitamin D3 (25[OH]D3) level less than 20 ng/mL prior to study initiation
- Willingness to comply with study guidelines
- Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
- Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Personal history of lung cancer or head and neck cancer
- History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
- History of known thyroid disease
- History of known sarcoid disease
- History of known abnormalities in calcium metabolism
- Hypercalcemia (serum calcium in excess of laboratory upper limit normal [ULN])
- Self-reported consumption of more than 4 alcoholic drinks per day
- Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
- History of known renal dysfunction
- History of known nephrolithiasis (kidney stones)
- Current use of supplemental oxygen
- Inability to exercise due to musculoskeletal issue, osteoarthritis or underlying cardiac disease
- Current participation in a cancer intervention prevention study, except for smoking cessation
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
- Inability to swallow pills
- Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment
- Positive Pregnancy Test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control arm (multivitamin, placebo)
Patients receive a placebo and multivitamin orally each day for 52 weeks.
|
Correlative studies
Given PO
Other Names:
Ancillary studies
Given PO
Other Names:
|
Experimental: Supplementation arm (multivitamin, cholecalciferol)
Patients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks.
|
Correlative studies
Ancillary studies
Given PO
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Time Frame: At 12 months
|
75% will be considered a success.
|
At 12 months
|
Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)
Time Frame: Baseline to 24 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)
Time Frame: Baseline to 24 weeks
|
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
|
Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)
Time Frame: Baseline to 24 weeks
|
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)
Time Frame: At 3 months
|
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)
Time Frame: At 6 months
|
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)
Time Frame: Baseline to 24 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in correlative biomarkers of lung cancer risk, inflammation, and pulmonary function (UPCI study)
Time Frame: Baseline to up to 1 year
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Muscle Weakness
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
Other Study ID Numbers
- I 240913 (Other Identifier: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- P50CA090440 (U.S. NIH Grant/Contract)
- NCI-2016-00524 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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