Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT05431920
Eligibility Criteria:
Inclusion Criteria:
* Adolescents of 12 to 17 years old.
* Diagnosis of exogen obesity with a body mass index (BMI) greater than percentile 95 for age and sex, according to the Center for Disease Control and Prevention (CDC) graphics, that precedes the diagnosis of asthma.
* Plasmatic concentration of 25-hydroxyvitamin D less than 30 ng/ml at screening visit based on local laboratory test.
* Physician-diagnosed asthma, with more than 6 months of evolution, based on medical history, physical examination, clinical criteria according to the Global Initiative For Asthma 2020 (GINA) and confirmed with a spirometry with reversibility after the administration of a bronchodilator.
* Asthma severity (intermittent or mild persistent or moderate persistent) according to the National Asthma Education and Prevention Program (NAEPP) and classified as controlled, partly controlled or uncontrolled according to GINA 2020.
* Negative allergic skin tests.
Exclusion Criteria:
* History of systemic or chronic degenerative disease (renal, pulmonar, cardiovascular, infectious, muscular, immunological, hypertension, diabetes mellitus, cancer, nonalcoholic fatty liver disease).
* Current treatment with immunomodulators or immunostimulants, up to 6 months before the intervention.
* History of adverse effects to vitamin D.
* Treatment with oral steroids 3 months previous to the enrollment.
* Active smoking.
Elimination criteria:
* Parents, tutors, legal guardians or participants that decide to withdraw from the study any time.
* Pregnancy during study.
* Severe adverse effects to vitamin D.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05431920
Study Brief:
Protocol Section:
NCT05431920