Vitamin D and Grass Pollen Specific Immunotherapy

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.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

given orally, once daily, before grass pollen season

Other names: Vitamin D

middle-chain fatty acids (carrier)

Other

given orally, once daily, before grass pollen season

Other names: neutral oil

Primary outcomes

wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo

Time frame: three years

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Nov 8, 2011
Registry last updated: Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed