Vitamin D and Grass Pollen Specific Immunotherapy

Charité University Medicine Berlin

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinoconjunctivitis

Treatments: Other: middle-chain fatty acids (carrier); Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01466465

2010-021775-80 (EudraCT Number)

ProGIT

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

35 participants in 2 patient groups, including a placebo group

Vigantol

Experimental group

Treatment:

Drug: Cholecalciferol

neutral oil (vigantol carrier)

Placebo Comparator group

Treatment:

Other: middle-chain fatty acids (carrier)