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Vitamin D and Grass Pollen Specific Immunotherapy

Primary Purpose

Allergic Rhinoconjunctivitis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Cholecalciferol

middle-chain fatty acids (carrier)

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vigantol

neutral oil (vigantol carrier)

Arm Description

Outcomes

Primary Outcome Measures

wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo

Secondary Outcome Measures

Full Information

NCT ID

NCT01466465

First Posted

November 1, 2011

Last Updated

June 24, 2015

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT01466465

Brief Title

Vitamin D and Grass Pollen Specific Immunotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinoconjunctivitis

Keywords

Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vigantol

Arm Type

Experimental

Arm Title

neutral oil (vigantol carrier)

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vitamin D

Intervention Description

given orally, once daily, before grass pollen season

Intervention Type

Other

Intervention Name(s)

middle-chain fatty acids (carrier)

Other Intervention Name(s)

neutral oil

Intervention Description

given orally, once daily, before grass pollen season

Primary Outcome Measure Information:

Title

wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo

Time Frame

three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Worm Margitta, MD, Prof.

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Vitamin D and Grass Pollen Specific Immunotherapy

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