NCT05431920Active, not recruiting
Effects of Vitamin D Supplementation in Adolescents With Asthma, Obesity and Vitamin D Deficiency.
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- First submitted
- 8 Jun 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- NCT number
- NCT05431920
What you commit to
- Study type: Interventional
- Planned participants: 264
- From 1 Oct 2022 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with immunomodulators or immunostimulants, up to 6 months before the intervention.
- Treatment with oral steroids 3 months previous to the enrollment.
Other illness
- History of systemic or chronic degenerative disease (renal, pulmonar, cardiovascular, infectious, muscular, immunological, hypertension, diabetes mellitus, cancer, nonalcoholic fatty liver disease).
- History of adverse effects to vitamin D.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Infantil de Mexico Federico Gomez Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.