Chronic Obstructive Lung Disease
Conditions
Keywords
COPD, Vitamin D, Pulmonary rehabilitation
Brief summary
The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.
Interventions
DIETARY_SUPPLEMENTVitamin D (D3, cholecalciferol)
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
DIETARY_SUPPLEMENTPlacebo (cellulose)
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
Sponsors
Jorgen Vestbo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal from rehabilitation. | 24 weeks | Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks. |
| Improvement in walking distance | 24 weeks | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life. | 52 weeks | COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ). |
| Change in status of bone metabolism. | 52 weeks | DXA (Dual energy X-ray Absorptiometry) scans |
| Change in walking distance. | 52 weeks | 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)). |
| Change in fat mass and fat free mass. | 52 weeks | Whole body DXA scans. |
| Change in vitamin D status. | 52 weeks | se-25-OHD se-PTH |
| COPD exacerbations. | 52 weeks | — |
| All cause hospital admissions. | 52 weeks | — |
| All cause mortality. | 52 weeks. | — |
| Change in physical activity. | 24 weeks | Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband). |
| Change in calcium metabolic status. | 52 weeks | se-calcium se-phosphate se-magnesium |
Countries
Denmark
Outcome results
None listed