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Adjunctive vitamin A and vitamin D3 (Cholecalciferol) for enhancing efficacy of allergen-specific immunotherapy in allergic rhinitis, A randomized, double-blind, placebo-controlled trial

Adjunctive vitamin A and vitamin D3 (Cholecalciferol) for enhancing efficacy of allergen-specific immunotherapy in allergic rhinitis, A randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210129003
Enrollment
48
Registered
2021-01-29
Start date
2021-02-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

House dust mite sensitization allergic rhinitis Immunotherapy allergic rhinitis house dust mite sensitization vitamin A vitamin D3 dysfunctional T-reg

Interventions

Vitamin A 25,000 IU/week with Vitamin D3 50,000 IU/week,Vitamin D3 50,000 IU/week + Placebo 1 tab/week,Placebo 2 tabs/week
Vitamin A + Vitamin D3,Vitamin D3 + Placebo,Placebo

Sponsors

Department of Medicine, Phramongkutklao hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Allergic rhinitis with house dust mite sensitization (mono- or polysensitization) with or without asthma 2. No previous treatment with immunotherapy, or quit more than 6 month if the patient used to treatment with immunotherapy 3. Vitamin D level < 30 ng/mL 4. Calcium level < 10.5 mg/dL 5. No pregnant/breastfeeding 6. Accept to intake vitamin A and Vitamin D3

Exclusion criteria

Exclusion criteria: 1.Patients have contraindication for Vitamin A or Vitamin D3 intake eg, Allergy to vitamin 2. Uncontrolled asthma 3. Abnormal kidney or liver function 4. Underlying cardiac disease, Immunodeficiency 5. On treatment with immunosuppressive drugs/chemotherapy 6. Pregnant or breastfeeding 7. Already intake vitamin A or vitamin D3 before enrollment 8. Vitamin D level > 80 ng/mL 9. Vitamin A level > 60 mcg/mL 10. Calcium level > 10.5 mg/dL

Design outcomes

Primary

MeasureTime frame
Nasal symptoms At 10 week and 20 week after start treatment Total nasal symptoms score, total nasal symptoms/medication score

Secondary

MeasureTime frame
Dysfunctional T-reg At 10 week and 20 week after start treatment Laboratory assessment for Dysfunctional T-reg

Countries

Thailand

Contacts

Public ContactSopit Siriwongmongkol

Phramongkutklao hospital

Piggy_oozzy@hotmail.com0858665990

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026