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Vitamin D levels in adults with non-atopic asthma: A case-control study.


- candidate number8704
- NTR NumberNTR2620
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2010
- Secondary IDsNL 33519.099.10 CCMO
- Public TitleVitamin D levels in adults with non-atopic asthma: A case-control study.
- Scientific TitleVitamin D levels in adults with non-atopic asthma: A case-control study.
- ACRONYMPanama deel 5
- hypothesisWe hypothesize that vitamin D levels in non-atopic asthma are lower than those in atopic asthmatics and healthy non-atopic controls.
- Healt Condition(s) or Problem(s) studiedAsthma, Vitamin D, Non-atopic asthma
- Inclusion criteriaGroup 1:
1. Outpatients with non-atopic asthma, determined by negative alatop;
2. Age ≥ 18 yrs;
3. Pulmonologists diagnosis of asthma;
4. Documented reversibility in FEV1 of > 12% predicted OR airway hyperresponsiveness to inhaled methacholine.

Group 2:
1. Outpatients with atopic asthma, determined by known positive alatop or skin prick test;
2. Age ≥ 18 yrs;
3. Pulmonologists diagnosis of asthma;
4. Documented reversibility in FEV1 of > 12% predicted OR airway hyperresponsiveness to inhaled methacholine.

Group 3:
1. Subjects without pulmonary history or pulmonary complaints;
2. Age ≥ 18 yrs;
3. No signs of allergy and negative alatop;
4. Normal spirometry.
- Exclusion criteriaGroup 1:
1. Patients with smoking history of > 10 packyears and persistent airflow obstruction (post bronchodilator FEV1 < 80%pred): excluded if reversibility in FEV1 < 12% predicted OR TLCO < 80%pred;
2. Pregnancy;
3. Use of supplements containing vitamin D analogues in the last 6 months;
4. Other pulmonary diseases.

Group 2:
1. Patients with smoking history of > 10 packyears and persistent airflow obstruction (post bronchodilator FEV1 < 80%pred): excluded if reversibility in FEV1 < 12% predicted OR TLCO < 80%pred;
2. Pregnancy;
3. Use of supplements containing vitamin D analogues in the last 6 months;
4. Other pulmonary diseases.

Group 3:
1. Pulmonary history or current pulmonary complaints;
2. Use of supplements containing vitamin D analogues in the last 6 months;
3. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-nov-2010
- planned closingdate31-dec-2011
- Target number of participants216
- InterventionsN/A
- Primary outcome1. The difference between vitamin D levels of patients with non-atopic asthma and of patients with atopic asthma;
2. The difference between vitamin D levels of patients with non-atopic asthma and of non-atopic healthy subjects.
- Secondary outcomeNot applicable at this time.
If a difference is found between non-atopic asthmatics and controls, virus serology will be determined and compared between these groups and genetic tests can be performed and compared between these groups.
- TimepointsWhen patients are included, one visit is planned. No further appointments are made.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J.C. Groot, de
- CONTACT for SCIENTIFIC QUERIES J.C. Groot, de
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Stichting Longgeneeskunde Fryslan
- PublicationsN/A
- Brief summaryRationale:
Vitamin D levels have been linked to asthma and respiratory tract infections. The mechanism of this association is not yet totally understood, but vitamin D seems to have an immune modulatory effect and play a role in host defence against infections. The role of vitamin D in asthma, could especially be important in non-atopic patients, since non-atopic asthma often starts after a respiratory tract infection. Data on vitamin D levels in non-atopic asthma are lacking. By comparing vitamin D levels in non-atopic asthma patients to those in atopic asthmatics and in healthy non-atopic controls, the role of vitamin D might be better understood.

Objective:
To compare the levels of vitamin D in subjects with non-atopic asthma to those in subjects with atopic asthma and those in healthy non-atopic subjects.

Study design:
Case-control study.

Study population:
Adult patients with non-atopic asthma will be recruited from a large cohort of non-atopic asthma patients, composed in a previous study (PANAMA 1-3).
Two other groups will be composed: One group of atopic asthma patients and one group of healthy non-atopic controls. These two groups will be matched to the non-atopic asthma group for age, sex and BMI.

Main study parameters/endpoints:
The difference between vitamin D levels of patients with non-atopic asthma and patients with atopic asthma and the difference between vitamin D levels of patients with non-atopic asthma and healthy non-atopic subjects.
- Main changes (audit trail)
- RECORD24-nov-2010 - 4-dec-2010


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