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

Phase 4
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
Registration Number
TCTR20190813001
Lead Sponsor
Phramongkutklao Medicine Foundation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Enrolling by invitation
Sex
All
Target Recruitment
30
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical score TNSS, ACT, PEFR 10 weeks and 20 weeks Questionnaire
Secondary Outcome Measures
NameTimeMethod
aboratory 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
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