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Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease, Muscle Weakness

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Laboratory Biomarker Analysis
Multivitamin
Placebo
Questionnaire Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Current Smoker, Former Smoker

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm (multivitamin, placebo)

Supplementation arm (multivitamin, cholecalciferol)

Arm Description

Patients receive a placebo and multivitamin orally each day for 52 weeks.

Patients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks.

Outcomes

Primary Outcome Measures

Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
75% will be considered a success.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 17, 2016
Last Updated
February 14, 2017
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02877641
Brief Title
Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease
Official Title
Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
April 16, 2014 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Muscle Weakness
Keywords
Current Smoker, Former Smoker

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm (multivitamin, placebo)
Arm Type
Active Comparator
Arm Description
Patients receive a placebo and multivitamin orally each day for 52 weeks.
Arm Title
Supplementation arm (multivitamin, cholecalciferol)
Arm Type
Experimental
Arm Description
Patients receive a multivitamin and cholecalciferol supplement orally each day for 52 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamin
Other Intervention Name(s)
Geritol, Vitamin Supplements (NOS)
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Description
75% will be considered a success.
Time Frame
At 12 months
Title
Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)
Description
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.
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)
Description
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.
Time Frame
Baseline to 24 weeks
Title
Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)
Description
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.
Time Frame
Baseline to 24 weeks
Title
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Description
Efficacy in in COPD patients who are current versus former smokers will be compared.
Time Frame
At 3 months
Title
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Description
Efficacy in in COPD patients who are current versus former smokers will be compared.
Time Frame
At 6 months
Title
Change in peripheral muscle strength assessed by squat test (RPCI/UB study)
Description
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.
Time Frame
Baseline to 24 weeks
Other Pre-specified Outcome Measures:
Title
Change in correlative biomarkers of lung cancer risk, inflammation, and pulmonary function (UPCI study)
Description
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.
Time Frame
Baseline to up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Mahoney
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease

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