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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163735




Registration number
NCT00163735
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
5/12/2013

Titles & IDs
Public title
Potential Allergens in Wine: Double-blind Placebo-controlled Trial
Scientific title
Potential Allergens in Wine: Double Blind Placebo-controlled Trial and Basophil Activation Analysis
Secondary ID [1] 0 0
Number 124/02
Secondary ID [2] 0 0
124/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 0 0
Anaphylaxis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Administration of wine fined with potential food allergens

Treatment: Drugs: Administration of wine fined with potential food allergens
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Allergic reactions to wine
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Positive basophil activiation test to wines
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Individuals with IgE-mediated food allergy to milk, fish, egg or nuts Otherwise no major
medical problems Able to drink wine -
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major asthma or cardiac disease Unwilling or unable to participate

-

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
AIR Med, Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Wine Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Alfred
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to identify whether wines which are produced using the common
potential food allergens such as proteins derived from fish, milk or egg are likely to
contain sufficient food allergens to cause allergic reactions in susceptible individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163735
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn E O'Hehir, MBBS PhD FRACP
Address 0 0
Alfred Hospital and Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163735