Vitamin D supplementation for adolescents with asthma and obesity

Effects of Vitamin D3 Supplementation in Asthma Control, Pulmonary Function and Th17 Inflammatory Biomarkers in Adolescents With Asthma, Obesity and Vitamin D Deficiency: a Randomized Clinical Trial

This study is testing if giving high doses of vitamin D can help teenagers with asthma and obesity breathe better and feel healthier.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Hospital Infantil de Mexico Federico Gomez (Academic / other)
• Locations: 1 site (Mexico City)
• Trial ID: NCT05431920 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of oral vitamin D3 supplementation on adolescents aged 12-17 who have non-allergic asthma, obesity, and vitamin D deficiency. Participants will be randomly assigned to receive either a high dose of vitamin D (50,000 IU single dose plus 4,000 IU daily) or a lower dose (2,000 IU daily) for three months. The study will assess asthma control, the incidence of asthmatic crises, lung function, and inflammatory biomarkers through various clinical evaluations and blood tests. The goal is to determine if vitamin D supplementation can improve asthma management in this specific population.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-17 with obesity, vitamin D deficiency, and a diagnosis of non-allergic asthma.

Not a fit: Patients with allergic asthma or those not meeting the criteria for obesity and vitamin D deficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved asthma control and reduced severity of asthma crises in adolescents with obesity and vitamin D deficiency.

How similar studies have performed: Other studies have suggested potential benefits of vitamin D supplementation in asthma management, but this specific approach in adolescents with obesity is relatively novel.

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.

Where this trial is running

Mexico City

• Hospital Infantil de México Federico Gómez — Mexico City, Mexico (Recruiting)

Study contacts

• Study coordinator: Blanca Estela Del Río Navarro, MD

Conditions Non-allergic Asthma; Obesity; Vitamin D Deficiency; asthma; obesity; non allergic asthma; adolescents; vitamin D