Status:
ACTIVE_NOT_RECRUITING
Effects of Vitamin D Supplementation in Adolescents With Asthma, Obesity and Vitamin D Deficiency.
Lead Sponsor:
Hospital Infantil de Mexico Federico Gomez
Conditions:
Non-allergic Asthma
Obesity
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
Obesity has been associated with a specific non-allergic asthma phenotype and to a deficiency of vitamin D in at least 90% of the pediatric population. Adolescents with non-allergic asthma and vitamin...
Detailed Description
Randomized controlled, double-blind, parallel (2 arms), clinical trial. Eligibility criteria: adolescents (12-17 years old), with obesity, vitamin D deficiency (\<30 ng/dl), controlled or partially co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT05431920
Start Date
October 1 2022
End Date
December 31 2026
Last Update
September 15 2025
Active Locations (1)
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1
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, Mexico, 06720