One hundred and sixty children with allergic or non-allergic asthma, deficit, insufficiency or normal levels of Vitamin D.
Conditions
Interventions
Trade Name: Vitamina D Kern Pharma
Product Name: Vitamin D
Product Code: 654778
Pharmaceutical Form: Oral drops, solution
Pharmaceutical form of the placebo: Oral drops
Route of administration of the
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
Kern Pharma, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children between 6 and 18 years, with allergic asthma or non allergic asthma, with frequent or moderate episodics with good clinical control and respiratory function, with or without deficit of vitamin D. 2. Acceptance by the parents, with the sign in the informed consent. 3. In some subgroups, the patients should comply with the criteria established.(deficit or insufficiency of Vitamin D). Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not acceptance by the parents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To know if there is any significant association between asthma and vitamin D deficiency.;Secondary Objective: 2. To know if the treatment of vitamin D deficit, decrease the number of exacerbations of asthma, daytime cough, nocturnal cough, dyspnea on exertion, allergic rinconjuntivitis, the need for basic treatment, the number of visits to an emergency department for asthma, the number of hospital admissions for asthma and markers of airway inflammation (exhaled nitric oxide). 3. To know if there is any difference in response to treatment with vitamin D according to the etiological origin (allergic or non allergic).;Primary end point(s): CAN questionary - Asthma control Asthma classification according to the GEMA 2009 classification Exhaled nitric oxide Sun exposure Type of alimentation Leveles of vitamin D Spirometry test Prick test Análisis de sangre;Timepoint(s) of evaluation of this end point: No | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NO;Timepoint(s) of evaluation of this end point: NO | — |
Countries
Spain
Contacts
Public ContactDra. Rosa Mª
Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
Outcome results
None listed