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NCT05431920

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

Active, enrolled NA Last updated 15 September 2025
What this trial tests

NA trial testing Vitamin D₃ (25-hydroxy vitamin D) in Non-allergic Asthma in 264 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 October 2022
Primary endpoint
1 December 2025
31 December 2026

Quick facts

Lead sponsorHospital Infantil de Mexico Federico Gomez
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment264
Start date1 October 2022
Primary completion1 December 2025
Estimated completion31 December 2026
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Infantil de Mexico Federico Gomez

Who can join

Adults 12 to 17, any sex, with Non-allergic Asthma or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Management of the pediatric patient with asthma and obesity.
    Averill SH, Forno E. · · 2024 · cited 10× · PMID 37827386 · DOI 10.1016/j.anai.2023.10.001
  2. Gaps and Future Directions in Clinical Research on Obesity-Related Asthma.
    Hudler AC, Díaz IRR, Sharma S, Holguin F. · · 2023 · cited 5× · PMID 37330948 · DOI 10.1007/s41030-023-00230-2
  3. Obesity: Next game changer of allergic airway diseases?
    Li W, Marx N, Yang Q, Fang D, et al · · 2025 · cited 2× · PMID 40329860 · DOI 10.1002/ctm2.70316

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Trials by the same sponsor.

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