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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-16

Study Completion Date

2017-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Intervention Type OTHER

Ancillary studies

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9,10-Secocholesta-5,7,10(19)-trien-3-ol Calciol Delsterol Vitamin D3 Geritol Vitamin Supplements (NOS) placebo therapy PLCB sham therapy

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No