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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014