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

Launched by HOSPITAL INFANTIL DE MEXICO FEDERICO GOMEZ · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of vitamin D supplementation in adolescents aged 12 to 17 who have non-allergic asthma, obesity, and low levels of vitamin D. The purpose of the study is to see if taking vitamin D can improve asthma control, reduce the number of asthma attacks, enhance lung function, and affect certain inflammation markers in the body. Participants will receive either a single high dose of vitamin D or daily doses for three months to determine which is more effective.

To be eligible for the study, participants must be diagnosed with obesity and asthma, have low vitamin D levels, and show specific asthma symptoms for at least six months. They should not have any serious health conditions or be taking certain medications that could interfere with the study. Those who join can expect to be closely monitored and may help improve understanding of how vitamin D can impact asthma in adolescents. This trial is currently recruiting participants, and your involvement could contribute to important research in this area.

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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.