NL-OMON44715
Completed
Phase 4
Prevention of exacerbations in patients with COPD through vitamin D supplementation: a randomized controlled trial - COPD and vitamin D (PRECOVID)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- chronic obstructive pulmonary disease
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 240
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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