Vitamin D and Grass Pollen Specific Immunotherapy

June 24, 2015 updated by: Margitta Worm, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vigantol
Drug: Cholecalciferol
given orally, once daily, before grass pollen season
Other Names:
  • Vitamin D
PLACEBO_COMPARATOR: neutral oil (vigantol carrier)
Other: middle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season
Other Names:
  • neutral oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Worm Margitta, MD, Prof., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (ESTIMATE)

November 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProGIT
  • 2010-021775-80 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinoconjunctivitis

Clinical Trials on Cholecalciferol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe