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Onderzoek naar de effecten van vitamine D op de longfunctie, luchtweginfecties en lichamelijke conditie bij COPD-patiŽnten.


- candidate number9282
- NTR NumberNTR2827
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mrt-2011
- Secondary IDs 
- Public TitleOnderzoek naar de effecten van vitamine D op de longfunctie, luchtweginfecties en lichamelijke conditie bij COPD-patiŽnten.
- Scientific TitleEffects of vitamin D supplementation on pulmonary function, airway infections and physical performance in patients with COPD: A randomized controlled trial.
- ACRONYM
- hypothesisAlthough 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.
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD)
- Inclusion criteria1. Written informed consent;
2. Aged between 40 and 75 years;
3. Diagnosis COPD performed by the pulmonologist;
4. Vitamin D deficiency (defined as a serum 25-hydroxyvitamin D < 50 nmol/l).
- Exclusion criteria1. Severe vitamin D deficiency (serum 25-hydroxyvitamin D <15 nmol/L);
2. Life expectation of less than 6 months on the basis of concurrent disease;
3. Interfering malignant diseases;
4. 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;
5. Pregnant or lactating women, or subjects who intend to become pregnant within the study period.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-mrt-2012
- Target number of participants120
- InterventionsThe intervention group will receive vitamin D3 1200 IU orally once a day. The control group will receive a placebo orally once a day.
- Primary outcomeThe main study parameters are the serum concentration 25-hydroxyvitamin D, the pulmonary function parameters FEV1 and FVC, the incidence of airway infections, the scores on the physical performance tests and the scores on the LASA physical activity questionnaire (LAPAQ).
- Secondary outcomeN/A
- TimepointsDuring the study there will be three visits. Measurements will be conducted at baseline before randomisation (t=0), at 3 months (t=3) and at 6 months (t=6) after randomisation. During every visit the patients will undergo spirometry, a blood sample will be drawn, a questionnaire on functional limitations will be filled in, and physical performance tests will be done. The participants will also receive a diary card to register the incidence of airway infections during the study period.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. P. Lips
- CONTACT for SCIENTIFIC QUERIESProf. P. Lips
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryRationale:
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.

Objective:
To assess the effect of vitamin D supplementation on pulmonary function, the incidence of airway infections and physical performance in patients with COPD.

Study design:
Double-blind placebo-controlled intervention study.

Study population:
The study population will include 120 patients with COPD, aged between 40 and 75 years, who will be randomly allocated to one of two groups.

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.

Main study parameters/endpoints:
The main study parameters are the serum concentration 25-hydroxyvitamin D, the pulmonary function parameters FEV1 and FVC, the incidence of airway infections, the scores on the physical performance tests and the scores on the LASA physical activity questionnaire (LAPAQ).

Methods:
During the study there will be three visits. Measurements will be conducted at baseline before randomisation (t=0), at 3 months (t=3) and at 6 months (t=6) after randomisation. During every visit the patients will undergo spirometry, a blood sample will be drawn, a questionnaire on functional limitations will be filled in, and physical performance tests will be done. The participants will also receive a diary card to register the incidence of airway infections during the study period.
- Main changes (audit trail)
- RECORD29-mrt-2011 - 4-apr-2011


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