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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease, Muscle Weakness

In brief

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.

Key facts

Study ID

NCT02877641

Run by

Roswell Park Cancer Institute

People needed

4

Starts

2014-04-16

Expected to finish

2017-02-01

Last updated by the study team

2017-02-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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