To assess the effect of vitamin D supplementation on exacerbation rate in patients with COPD and a vitamin D deficiency.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exacerbation rate: an exacerbation is defined as sustained worsening of
respiratory symptoms during 48 hours and requiring oral corticosteroid,
antibiotic or combination treatment that was initiated by a physician.
Respiratory symptoms include at least one of the Anthonisen criteria (increased
dyspnoea, sputum volume or sputum purulence).
Secondary outcome
- Time to first and second exacerbation
- Time to first hospitalisation
- Number of upper respiratory tract infections
- Spirometry measures (forced FEV1, FEV1/FVC, IC and ERV)
- Lung volumes (FRC, RV and TLC)
- Maximal respiratory mouth pressures (MIP and MEP)
- Physical function tests: 6 minute walking test
- Physical function tests: chair stand test, walking test and tandem stand test
- Hand grip strength
- Quality of life (SGRQ, SF12 and CCQ)
- Anxiety and depression (HADS and CESD)
- Physical activity questionnaire (SQAUSH)
- Concentrations of antimicrobial peptides and pro-inflammatory mediators in
nasal secretions (LL-37, HNP1-3, NGAL, IFN-gamma,
IL-beta, TNFalpha, IL-6)
- Inflammation and host response against infectious agents (ex-vivo cytokine
production capacity of peripheral blood mononuclear
cells and immunophenotyping, platelet function)
- Typing of bacteria and viruses in nasal secretions (non-typeable H.
influenzae, S. pneumonia and M. catarrhalis, and a panel of
respiratory viruses including rhinovirus)
- Measurement of desmosine levels
- Systemic cytokine levels and effects thereof on osteoblast proliferation and
differentiation.
- Use of antibiotics
- Use of corticosteroids
Background summary
Although vitamin D is well known for its function in calcium homeostasis and
bone mineralisation, several studies have shown immunomodulatory effects of
vitamin D. Vitamin D deficiency is a common problem in patients with COPD.
Study objective
To assess the effect of vitamin D supplementation on exacerbation rate in
patients with COPD and a vitamin D deficiency.
Study design
Double-blind, randomized, controlled multicenter study
Intervention
2 groups: 3 tablets with in total 16.800 IU of vitamin D (colecalciferol) or
plabebo per week during one year
Study burden and risks
This study contains minimal risk for participants. The burden relates to three
hospital visits, blood samples to be drawn two times and the tests for lung
function and volumina, and physical function. In addition, nasal secretion
will be derived two times by a small suction device.
de Boelelaan 1117
Amsterdam 1081HV
NL
de Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002000-25-NL |
| ClinicalTrials.gov | NCT02122627 |
| CCMO | NL49411.029.14 |