To assess the effect of vitamin D supplementation on pulmonary function, the incidence of exacerbations and physical performance in patients with COPD.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are respiratory muscle strength (MIP and MEP) and scores
on physical performance tests.
Secondary outcome
Secondary endpoints are pulmonary function (FEV1 and FEV1/FVC), peak flow
measurements, scores on muscle strength tests, incidence of exacerbations,
concentrations of antimicrobial peptides in nasal seretion, bacterial and viral
nasal colonization, levels of inflammatory markers in sputum, and the scores
of the LASA physical activity questionnaire (LAPAQ), functional limitations
questionnaire, the Short Form 12-item Health Survey (SF-12) and the EQ-5D.
Background summary
Although vitamin D is well known for its function in calcium homeostasis and
bone mineralisation, several studies have shown an effect on pulmonary function
and incidence of airway infections. Vitamin D deficiency is a common problem in
patients with COPD. As vitamin D deficiency is associated with impaired
pulmonary function and a higher incidence of airway infections, supplementation
with vitamin D might have positive effects on these outcomes in patients with
COPD.
Study objective
To assess the effect of vitamin D supplementation on pulmonary function, the
incidence of exacerbations and physical performance in patients with COPD.
Study design
Double-blind placebo-controlled intervention study
Intervention
The intervention group will receive vitamin D3 1200 IU orally once a day. The
control group will receive a placebo orally once a day.
Study burden and risks
During the study there will be three visits. Visits will be performed at
baseline before randomisation (t=0), at 3 months (t=3) and at 6 months (t=6)
after randomisation.
At t=0 and t=6 patients will undergo spirometry and peak flow measurements,
maximal inspratory and expiratory pressure will be measured, a blood sample
will be drawn, a nasal secretion and swab sample will be obtained,
questionnaires on physical activity, functional limitations and physical and
mental health will be completed, and physical performance and muscle strength
tests will be done. In Medical Center Alkmaar also a sputum sample will be
obtained by sputum induction. At t=3 patients will perform a peak flow
measurement and physical performance tests. Also, questionnaires on physical
activity, functional limitations and physical and mental health will be
completed. The participants will receive a diary card to registrate the
incidence of exacerbations and changes in medication during the study period.
The amount of blood that is taken at t=0 and t=6 is 16 mL. The participants may
experience some discomfort during the physical performance tests, acquisition
of nasal secretion, induction of sputum and venapunction. Participating in the
study has marginal risks as the supplemented dose of 1200 IU vitamin D3 is well
below the maximum advice of 2000 IU of the Health Council of the Netherlands.
Participants will receive the results of the pulmonary function tests and
physical performance tests after the end of the study period.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
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 |
|---|---|
| Other | Nederlands Trial Register: NTR2827 |
| CCMO | NL36386.029.11 |