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
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Vitamin D, SIT, Grass pollen, allergic rhinoconjunctivitis
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
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
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
Learn more about this trial
Vitamin D and Grass Pollen Specific Immunotherapy
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