NCT01466465

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

November 1, 2011

Last Update Submit

June 24, 2015

Conditions

Allergic Rhinoconjunctivitis

Keywords

Vitamin DSITGrass pollenallergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

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

    three years

Study Arms (2)

Vigantol

EXPERIMENTAL
Drug: Cholecalciferol

neutral oil (vigantol carrier)

PLACEBO COMPARATOR
Other: middle-chain fatty acids (carrier)

Interventions

CholecalciferolDRUG

given orally, once daily, before grass pollen season

Also known as: Vitamin D
Vigantol
middle-chain fatty acids (carrier)OTHER

given orally, once daily, before grass pollen season

Also known as: neutral oil
neutral oil (vigantol carrier)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • current specific immunotherapy
  • instable allergic asthma
  • pregnancy and lactation
  • treatment with immunomodulators or immunosuppressive drugs
  • sarcoidosis, chronic diseases, malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

CholecalciferolVitamin DCarrier State

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipidsEpidemiologic MethodsPublic HealthEnvironment and Public Health

Study Officials

  • Worm Margitta, MD, Prof.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 8, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

DE(1)