Active — Not RecruitingNot Applicable

Effects of Vitamin D Supplementation in Adolescents With Asthma, Obesity and Vitamin D Deficiency.

Mexico264 participantsStarted 2022-10-01

Plain-language 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 D deficiency have up to six times the risk \[OR: 6.2 (IC95% 2.0-21.6), p=0.002\] of having a severe asthmatic crisis and do not respond adequately to inhaled steroid treatment. To evaluate the effect of oral vitamin D3 supplementation with 50,000 IU single dose and 4,000 IU daily vs 2,000 IU daily on the Asthma Control Questionnaire score, number and incidence of asthmatic crisis, lung function, and Th17 inflammatory biomarkers in adolescents with asthma associated to obesity and vitamin D insufficiency/deficiency for three months.

Who can participate

Age range12 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 wit…

What they're measuring

Evaluate the effects of vitamin D supplementation daily for three months on asthma symptoms.

Timeframe: 12 weeks

Trial details

NCT IDNCT05431920

SponsorHospital Infantil de Mexico Federico Gomez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01