Prevention of exacerbations in patients with COPD through vitamin D supplementation: a randomized controlled trial

Phase 4

Completed

Conditions: chronic obstructive pulmonary disease
10024967

Registration Number: NL-OMON44715

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

Written informed consent
Aged * 40 years
Postbronchodilator FEV1/FVC<0,70 and FEV1<80% (GOLD stages II-IV) and diagnosis COPD confirmed by a medical doctor.
Minimum of 10 packyears of smoking
Vitamin D deficiency (defined as a serum 25-hydroxyvitamin D < 50 nmol/l). Lab value should not be older than 8 weeks.
Ability to comply with all study requirements

Exclusion Criteria

Pregnant or lactating women, or subjects who intend to become pregnant within the study period
Self-reported history of hypercalciemia or nephrolithiasis
Self-reported presence of sarcoidosis
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
Diagnosed osteoporosis
Diagnosed asthma
Diagnosed chronic kidney disease stage 4 or higher (eGFR <= 29ml/min/1.73m2)
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
Use of maintenance dose oral corticosteroids
Use of multivitamin supplement or vitamin D supplement which contains more than 400 IU per day
Current participation in a clinical rehabilitation programme. Patients can be included from the day after they have finished the programme.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Exacerbation rate: an exacerbation is defined as sustained worsening of<br /><br>respiratory symptoms during 48 hours and requiring oral corticosteroid,<br /><br>antibiotic or combination treatment that was initiated by a physician.<br /><br>Respiratory symptoms include at least one of the Anthonisen criteria (increased<br /><br>dyspnoea, sputum volume or sputum purulence).</p><br>

Secondary Outcome Measures