Effect of vitamin D supplementation on pulmonary function, airway infections and physical performance in patients with COPD: a randomized controlled trial

Completed

Conditions: chronic bronchitis
Chronic obstructive pulmonary disease
10024970

Registration Number: NL-OMON38400

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

- Written informed consent
- Aged between 40 and 70 years
- Postbronchodilator FEV1/FVC <70% and FEV1 <80% (GOLD-stages I-IV) and diagnosis COPD confirmed by the pulmonologist:
- Vitamin D deficiency (defined as a serum 25-hydroxyvitamin D < 50 nmol/l)
- Ability to comply with all study requirements

Exclusion Criteria

- Severe vitamin D deficiency (serum 25-hydroxyvitamin D <15 nmol/L),
- Life expectation of less than 6 months on the basis of concurrent disease
- Interfering malignant diseases.
- Serious mental impairment i.e. preventing to understand the study protocol or comply with the study aim; potentially unreliable patients and those judged by the investigator to be unsuitable for the study.
- Pregnant or lactating women, or subjects who intend to become pregnant within the study period.
- Clinical suspicion of osteoporosis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are respiratory muscle strength (MIP and MEP) and scores<br /><br>on physical performance tests.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are pulmonary function (FEV1 and FEV1/FVC), peak flow<br /><br>measurements, scores on muscle strength tests, incidence of exacerbations,<br /><br>concentrations of antimicrobial peptides in nasal seretion, bacterial and viral<br /><br>nasal colonization, levels of inflammatory markers in sputum, and the scores<br /><br>of the LASA physical activity questionnaire (LAPAQ), functional limitations<br /><br>questionnaire, the Short Form 12-item Health Survey (SF-12) and the EQ-5D.</p><br>