Trial Review

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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/NCT00163839




Registration number
NCT00163839
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
16/02/2012

Titles & IDs
Public title
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
Scientific title
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria or Angioedema: A Randomised Controlled Study
Secondary ID [1] 0 0
Ph: 00613 9276 3063
Secondary ID [2] 0 0
30/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urticaria 0 0
Angioedema 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Dietary Therapy

Behaviour: Dietary Therapy
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The relative use of antihistamines (ie how many, how often)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- English Speaking

- Aged between 21 to 75 years

- 3 month history of Chronic Idiopathic Urticaria and/or Angioedema
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- age <21 and >75 years

- non english speaking

- systemic lupus erythematosis

- dysproteinemias

- thyrotoxicosis

- vasculitis

- infection

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study involves investigating the effects of a pseudoallergen-free (active) diet compared
with a control (placebo) diet in the treatment of Chronic Idiopathic Urticaria (CIU) and/or
Angioedema. The hypothesis is that over a four-week intervention period, the
pseudoallergen-free diet will be more effective than the placebo diet in reducing the
frequency and severity of CIU and/or Angioedema.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163839
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Connell, Masters
Address 0 0
Alfred Hospital, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kate L Connell, Masters
Address 0 0
Country 0 0
Phone 0 0
0061 3 9276 3063
Fax 0 0
Email 0 0
k.connell@alfred.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163839