THE IMPACT OF VITAMIN D ON PHYSICAL TRAINING OF VITAMIN D DEFICIENT PATIENTS WITH COPD: A PROSPECTIVE RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND MULTI-CENTRE STUDY

Phase 1

• Conditions: Patients with chronic obstructive pulmonary disease (COPD) and concomitant vitamin D deficiency; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001250-41-SE
• Lead Sponsor: Region Östergötland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 < 0.7)
•No reversibility defined as < 12 % increase of FEV1 and FVC and < 200 ml increase of FEV1 after bronchodilation
•FEV1 < 60 % predicted or FEV1 = 60 % and < 80 % given that mMRC = 2 and/or CAT = 10
•PI max < 60 cm H2O
•serum-25(OH)D = 50 nmol/L
•suitable for supervised training in hospital as judged by the physiotherapist

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified