Dual supplementation with vitamin D and dietary fiber improves airway inflammation and Th1/Th2 balance in children with allergic asthma

Dual supplementation with vitamin D and dietary fiber improves airway inflammation and Th1/Th2 balance in pediatric patients with allergic asthma: A randomized, double-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202511724883695

Enrollment

Registered

2025-11-03

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Paediatrics

Interventions

Vitamin D supplementation

Dietary Fiber supplementation

Combined Vitamin D and Dietary Fiber supplementation

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Children aged 5 to 17 years • Clinically diagnosed with allergic asthma associated with sensitization to one or more aeroallergens • Classified as partially controlled or uncontrolled asthma according to GINA guidelines • Residing in the same geographical area (Tlemcen Department) with consistent dietary habits • Eutrophic (normal nutritional status) • On standard background asthma therapy with good therapeutic adherence and regular follow-ups • Parental/guardian informed consent obtained

Exclusion criteria

Exclusion criteria: • Presence of co-morbidities (obesity, active infections within 15 days before enrollment, autoimmune diseases, cancer, or other chronic inflammatory diseases) • Active smoking • Antibiotic treatment within the past month • Non-allergic asthma • Failure to comply with the study protocol or loss to follow-up during the study • Need for antibiotic therapy during the study period

Design outcomes

Primary

Measure	Time frame
Exhaled Breath Condensate Nitric Oxide (EBCNO) level, as a biomarker of airway inflammation.	—

Secondary

Measure	Time frame
Th1/Th2 cytokine balance.	—

Countries

Algeria

Contacts

Public ContactMohammed Chems Eddine Smahi

Neonatal Department of Specialized Maternal and Child Hospital of Tlemcen

mohammedchemdeddine.smahi@mail.univ-tlemcen.dz00213662142505

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026