Vitamin D and Grass Pollen Specific Immunotherapy | NCT01466465

Studies
Vitamin D and Grass Pollen Specific Immunotherapy

NCT01466465

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jun 25, 2015Estimated

Enrollment

35Actual

Phase

Phase 2

Conditions

Allergic Rhinoconjunctivitis

Interventions

Cholecalciferol
middle-chain fatty acids (carrier)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-021775-80	EudraCT Number

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Nov 1, 2011

First Submission Date that Met QC Criteria

Nov 7, 2011

First Posted Date

Nov 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2015

Last Update Posted Date

Jun 25, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Margitta Worm, Prof. Dr. med., Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vigantol	Experimental		Drug: Cholecalciferol
neutral oil (vigantol carrier)	Placebo Comparator		Other: middle-chain fatty acids (carrier)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug	given orally, once daily, before grass pollen season	Vigantol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo		three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Worm Margitta, MD, Prof.	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM		Berlin		10117	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol
D014807	Vitamin D
D002353	Carrier State

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided