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

Roswell Park Comprehensive Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease; Muscle Weakness

Treatments: Dietary Supplement: Multivitamin; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis; Other: Placebo; Dietary Supplement: Cholecalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02877641

P30CA016056 (U.S. NIH Grant/Contract)

I 240913 (Other Identifier)

NCI-2016-00524 (Registry Identifier)

P50CA090440 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Control arm (multivitamin, placebo)

Active Comparator group

Description:

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

Treatment:

Other: Placebo

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Dietary Supplement: Multivitamin

Supplementation arm (multivitamin, cholecalciferol)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Dietary Supplement: Multivitamin