Vitamin D and Chronic Obstructive Lung Disease

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.

Official Title
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Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance

Conditions
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Chronic Obstructive Lung Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin D (D3, cholecalciferol)
* Dietary Supplement: Placebo (cellulose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 50 % of predicted Breathlessness relative to MRC dyspnoea grade 3 or more Exclusion Criteria: Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease Patients with hyper- or hypocalcemia at inclusion Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia Patients taking more than 20 mcg vitamin D on a daily basis. If a patient takes vitamin D below this limit, dose should have been stable 6 months prior to inclusion in order to achieve steady-state. Pregnancy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D (D3, cholecalciferol)<br> | Dietary Supplement: Vitamin D (D3, cholecalciferol)<br>* Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)<br>* Other names: Bio Vinci Mega D-vitamin;|
| Placebo Comparator: Placebo (cellulose)<br> | Dietary Supplement: Placebo (cellulose)<br>* Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal from rehabilitation. | Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks. | 24 weeks | 
| Improvement in walking distance | Change in walking distance from week 0 to week 24. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test(ISWT) and Endurance Shuttle Walk Test (ESWT)). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin D status. | se-25-OHD se-PTH | 52 weeks | 
| Change in calcium metabolic status. | se-calcium se-phosphate se-magnesium | 52 weeks | 
| Change in quality of life. | COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ). | 52 weeks | 
| Change in status of bone metabolism. | DXA (Dual energy X-ray Absorptiometry) scans | 52 weeks | 
| Change in walking distance. | Change in walking distance from week 0 to week 11 and week 52. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)). | 52 weeks | 
| Change in fat mass and fat free mass. | Whole body DXA scans. | 52 weeks | 
| Change in physical activity. | Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband). | 24 weeks | 
| COPD exacerbations. |  | 52 weeks | 
| All cause hospital admissions. |  | 52 weeks | 
| All cause mortality. |  | 52 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Vitamin D, Pulmonary rehabilitation