Vitamin D and Grass Pollen Specific Immunotherapy

NCT ID: NCT01466465

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Rhinoconjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vigantol

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

given orally, once daily, before grass pollen season

neutral oil (vigantol carrier)

Group Type PLACEBO_COMPARATOR

middle-chain fatty acids (carrier)

Intervention Type OTHER

given orally, once daily, before grass pollen season

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cholecalciferol

given orally, once daily, before grass pollen season

Intervention Type DRUG

middle-chain fatty acids (carrier)

given orally, once daily, before grass pollen season

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vitamin D neutral oil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margitta Worm

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Worm Margitta, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-021775-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ProGIT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.