Vitamin D and Grass Pollen Specific Immunotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Margitta Worm, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01466465
First received: November 1, 2011
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Drug: Cholecalciferol
Other: middle-chain fatty acids (carrier)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vigantol Drug: Cholecalciferol
given orally, once daily, before grass pollen season
Other Name: Vitamin D
Placebo Comparator: neutral oil (vigantol carrier) Other: middle-chain fatty acids (carrier)
given orally, once daily, before grass pollen season
Other Name: neutral oil

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466465

Locations
Germany
Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Worm Margitta, MD, Prof. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Margitta Worm, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01466465     History of Changes
Other Study ID Numbers: ProGIT, 2010-021775-80
Study First Received: November 1, 2011
Last Updated: April 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Vitamin D
SIT
Grass pollen
allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014