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A multicenter, open label, randomized study to investigate the efficacy of subcutaneous immunotherapy combined with vitamin D3 in children and adolescent patients with allergic rhinitis

A multicenter, open label, randomized study to investigate the efficacy of subcutaneous immunotherapy combined with vitamin D3 in children and adolescent patients with allergic rhinitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093283
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-12-03
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Allergic rhinitis

Interventions

Treatment group A:SCIT and vitamin D3 in short-term
Treatment group B:SCIT and vitamin D3 in long-term
Treatment group C:SCIT

Sponsors

the Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) 5 years old =0.35 kU/L) caused by house dust mite (HDM); (4) Receiving standard anti-allergy medication for at least 1 year before enrollment; (5) Serum 25 (OH) D in normal levels .

Exclusion criteria

Exclusion criteria: (1) Subjects and/or parents/legal guardians have a low degree of expected compliance with the trial procedures or are unable to understand the instructions/trial documents; (2) Randomized treatment has been carried out before this trial; (3) A clear history of serious adverse reactions or anaphylactic shock has occurred in the past use of AIT; (4) Received dust mite-specific immunotherapy in the past 5 years; (5) Current or prior treatment with biologics (6) Patients with severe or uncontrolled asthma (FEV1<70% predicted) and the presence of irreversible airflow obstruction; (7) Patients using ß receptor blockers or angiotensin-converting enzyme (ACE) inhibitors; (8) Patients with severe autoimmune diseases, including immunodeficiency diseases and autoimmune diseases such as AIDS and inflammatory bowel disease, as well as patients with active infection, diabetes, gastric ulcer, etc.; (9) Patients with severe psychological disorders or patients who are not at risk of receiving treatment; Severe cardiovascular disease; Malignancy; (10) Patients supplemented with vitamin D.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale score;

Secondary

MeasureTime frame
Medical Score;

Countries

China

Contacts

Public ContactZhang Pingping

the Third Affiliated Hospital of Sun Yat-sen University

zhpingp@mail.sysu.edu.cn+86 138 2440 9324

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026