NCT05431920

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Hospital Infantil de Mexico Federico Gomez · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Randomized controlled, double-blind, parallel (2 arms), clinical trial. Eligibility criteria: adolescents (12-17 years old), with obesity, vitamin D deficiency (\<30 ng/dl), controlled or partially controlled or uncontrolled asthma according to GINA 2020 criteria and confirmed with a spirometry, with negative allergy skin test. To each patient it will be performed a medical history, physical examination, asthma control questionnaire, a spirometry (with bronchodilator), as well as a peripheral blood sample collection of 10 ml to measure Th17 inflammatory biomarkers by chemiluminescence immunoassay and quantitative polymerase chain reaction (genetic expression of 18 cytokines) and 25-hydroxyvitamin D plasmatic concentration with electrochemiluminescence. Patients will be randomized by block and assigned to one of two intervention arms. Each intervention arm will have a total sample of 132 patients. Experimental group will receive a single dose of 50,000 IU and 4,000 IU of vitamin D daily for 3 months. On the other hand, the active control group will receive 2,000 IU daily for 3 months. Patients will be followed up and cited every month for clinical assessment, asthma control (ACQ) questionnaire application, spirometry (with bronchodilator) and peripheral blood sample collection to determine the plasma concentration of 25-hydroxyvitamin D and Th17 inflammatory biomarkers.

Conditions

• Non-allergic Asthma
• Obesity
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D₃ (25-hydroxy vitamin D)	Vitamin D3 oral supplementation
DIETARY_SUPPLEMENT	Vitamin D₃ (25-hydroxy vitamin D)	Vitamin D3 oral supplementation

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-12-01
• Completion: 2026-12-31
• First posted: 2022-06-24
• Last updated: 2025-09-15

Locations

1 site across 1 country: Mexico