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Adjunctive vitamin d2 supplement in patient with allergen-specific immunotherapy randomized, double-blind, placebo-controlled trial

Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in the Build-up Phase of House Dust Mite-Specific Immunotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190813001
Enrollment
30
Registered
2019-08-13
Start date
2018-12-20
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Patients with allergic rhinitis and asthma begin treatment with allergen-specific immunotherapy. Calciferol, Vitamin D2 , allergic rhinitis, asthma, allergen-specific immunotherapy, TNSS score, ACT score, PEFR, Absolute eosinophil

Interventions

Oral vitamin d2 (Calciferol) 20&#44
000 iu 1 capsule on Monday&#44
and Friday,Placebo 1 capsule on Monday&#44
and Friday
Active Comparator Drug,Placebo Comparator Drug
Vitamin D2 (Calciferol) supplement,Placebo

Sponsors

Phramongkutklao Medicine Foundation
Lead Sponsor
Allergy and clinical immunology&#44
Collaborator
Internal medicine division&#44
Collaborator
Phramongkutklao hospital
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with allergic rhinitis and asthma. 2. Patients begin treatment with allergen-specific immunotherapy or Patients that used to treatment with allergen-specific immunotherapy and stop more than 6 months. 3. Patients decided to begin treatment with allergen-specific immunotherapy 4. Patient glad to join in this research and begin treatment with calciferol.

Exclusion criteria

Exclusion criteria: 1. Patients were contrandicated to recieve Calciferol such as allergy. 2. Patients with liver or kidney disease 3. Patients with severe adverse effect from allergen-specfic immunotherapy or calciferol 4. Patients with 25-OH Vitamin D level above 150 ng/mL before start research. 5. Patients with severe or uncontrolled asthma 6. Patients with underlying active heart disease such as Myocardial infarction in 4 weeks. 7. Patients with active malignancy and on going treatment with chemotherapy. 8. Patients with primary and secondary immunodeficiency. 9. Patients were included in the previous research within 30 days. 10.Pregnancy patients at any GA.

Design outcomes

Primary

MeasureTime frame
Clinical score TNSS, ACT, PEFR 10 weeks and 20 weeks Questionnaire

Secondary

MeasureTime frame
Laboratory Regulartory T cell, Absolute Eosinophil, IL-10, Der p 1-specific IgE and IgG4 levles 10 weeks and 20 weeks Blood drawing , flow cytometry, ELISA

Countries

Thailand

Contacts

Public ContactChirawat Chiewchalermsri

Phramongkutklao hospital

chirawatearth@gmail.com0989683561

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026