Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
时间窗: At 12 months
75% will be considered a success.
Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)
时间窗: 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.
次要结局
- Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)(Baseline to 24 weeks)
- Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)(Baseline to 24 weeks)
- Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)(At 6 months)
- Change in peripheral muscle strength assessed by squat test (RPCI/UB study)(Baseline to 24 weeks)