Vitamin D and Grass Pollen Specific Immunotherapy

Allergic Rhinoconjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466465
• Other study ID #: ProGIT
• Secondary ID: 2010-021775-80
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2011
• Last updated: June 24, 2015
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• written informed consent

• relative Vitamin D deficiency

• clinical relevant grass pollen allergy

• positive intradermal test with grass pollen

• forced expiratory volume at one second (FEV1) > 70%

Exclusion Criteria:

• current specific immunotherapy

• instable allergic asthma

• pregnancy and lactation

• treatment with immunomodulators or immunosuppressive drugs

• sarcoidosis, chronic diseases, malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Cholecalciferol
given orally, once daily, before grass pollen season

Other:
• middle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo		three years	No