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NCT05431920
Effects of Vitamin D Supplementation in Adolescents With Asthma, Obesity and Vitamin D Deficiency.
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.
1 December 2025
Quick facts
| Lead sponsor | Hospital Infantil de Mexico Federico Gomez |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 264 |
| Start date | 1 October 2022 |
| Primary completion | 1 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Vitamin D₃ (25-hydroxy vitamin D)
- Vitamin D₃ (25-hydroxy vitamin D)
Conditions studied
- Non-allergic Asthma — all drugs for Non-allergic Asthma →
- Obesity — all drugs for Obesity →
- Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
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):
-
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT05431920
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Hospital Infantil de Mexico Federico Gomez trials
Trials by the same sponsor.
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- NCT05276960 — Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF · Phase 4 · completed
- NCT03577600 — Compassionate Treatment in Children With Brain Tumors With the Cytotron® · NA · withdrawn
- NCT03951558 — Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria · NA · unknown
- NCT06174454 — Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05431920 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Infantil de Mexico Federico Gomez
- Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05431920.
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