Patients with chronic obstructive pulmonary disease (COPD) and concomitant vitamin D deficiency
Conditions
Interventions
Trade Name: Vigantol
Pharmaceutical Form: Oral drops, solution
Pharmaceutical form of the placebo: Oral drops, solution
Route of administration of the placebo: Oral use
Sponsors
Region Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent to participate in the study • Smoker or former smoker, = 10 package-yrs • Age = 55 yrs • COPD (defined as post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: • all contraindications /hypersensitivity to vitamin D3 • hypercalcemia (serum-Ca > 2.65 mmol/L) • primary hyperparathyroidism (hypercalcemia combined with PTH > 45 ng/L, reference 10-65 ng/L) • GFR, assessed by serum-cystatin C, < 45 mL/min/1.73 m2 • orthopedic, neurologic or mental impairment that would limit physical training • exacerbation of COPD and/or airway infection within 2 weeks prior to inclusion • significant anemia defined as hemoglobin < 110 g/L • recent myocardial infarct defined as < 6 months prior to inclusion • other serious disease (e.g. asystoli, stroke etc) that might hinder physical training as judged by the pysician • sarcoidosis or any other granuloma-forming inflammatory disease • treatment for neoplastic disease within the last 5 yrs • expected survival < 6 months • participation in supervised at hospital physical training finalized within the last 12 months • ongoing treatment with drugs that interact with vitamin D3 supplementation, e.g. cardiac glycosides, bensotiadiazin derivatives, phenytoin, barbiturates, rifampicin, isoniazid, orlistat and cholestyramine • participation in another interventional study within the last 12 months • previous participation in the present study • all contraindications to MR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to assess whether vitamin D3 supplementation, in addition to physical training, improves the strength of the respiratory muscles measured as increase of MIP.;Secondary Objective: Secondary objectives are to assess whether vitamin D3 supplementation, in addition to physical training, improves the strength of the respiratory muscles assessed by MEP and SNIP, muscle strength of dominant leg and arm, maximal oxygenation capacity (VO2max) and endurance measured with ISWT and ESWT, lung volumes at rest (FEV1 och FVC) after bronchodilation, physical functionality including balance, muscle metabolism in the quadriceps muscle of the dominant leg before, during and after standardized exercise applying 31P-MRS, quantification of muscle mass and fat in the dominant leg using MR, QoL, COPD symptoms, fatigue, physical activity, anxiety and depression, iBODE index (a product of BMI, FEV1 % of predicted, mMRC and ISWT), biological variables for systemic inflammation, oxidative stress and muscle- and bone pathology and serum-25(OH).;Primary end point(s): Primary outcome measure is strength of breathing muscles measured as maximal inspiratory pressure (MIP) after bronchodilation.;Timepoint(s) of evaluation of this end point: 13 weeks after inclusion (study visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • strength of breathing muscles after bronchdilation measured as MEP and SNIP • muscle strength of dominant leg and arm (measured as peak torque) • maximal oxygenation capacity (VO2max) and endurance measured with ISWT and ESWT • lung volumes at rest (FEV1 och FVC) after bronchodilation • Balance (SBPR) • muscle metabolism in the quadriceps muscle of the dominant leg before, during and after standardized exercise applying 31P-MRS • Quantification of muscle mass and fat in the dominant leg using MR • QoL (SGRQ) • COPD symptoms (mMRC and CAT) • Fatigue (MFI-20 and D-FIS) • Physical activity (IPAQ-S) • Anxiety and depression (HADS) • iBODE index (a product of BMI, FEV1 % of predicted, mMRC and ISWT) • Biological variables for systemic inflammation, oxidative stress and muscle- and bone pathology • Serum-25(OH)D before and after treatment with study medications ;Timepoint(s) of evaluation of this end point: 13 and 14 weeks after inclusion (study visits 4 and 5) | — |
Countries
Sweden
Contacts
Public ContactLennart Persson
Region Östergötland
Outcome results
None listed