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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)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
November 1, 2011
Last Updated
June 24, 2015
Sponsor
Charite University, Berlin, Germany
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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
No

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
No
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

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Vitamin D and Grass Pollen Specific Immunotherapy

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