Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05431920

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionNon-allergic Asthma, Obesity, Vitamin D Deficiency

Full registry 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.

Treatments and study arms

Vitamin D₃ (25-hydroxy vitamin D)

Dietary Supplement

Vitamin D3 oral supplementation

Vitamin D₃ (25-hydroxy vitamin D)

Dietary Supplement

Vitamin D3 oral supplementation

Primary outcomes

Evaluate the effects of vitamin D supplementation daily for three months on asthma symptoms.12 weeks

Evaluate the effects of vitamin D supplementation, with a single dose of 50,000 IU and 4,000 IU daily for three months, on asthma symptoms improvement (reduction of 0.5 in score compared to baseline), assessed by an asthma control questionnaire \[score range from 0 (fully controlled) to 6 (severely uncontrolled)\], compared to a dose of 2,000 IU daily.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Infantil de México Federico Gómez🇲🇽 Mexico City, Mexico City, Mexico

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