The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
Primary Purpose
Urticaria, Angioedema
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Dietary Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria focused on measuring Dietary Intervention, Pseudoallergen free diet
Eligibility Criteria
Inclusion Criteria: English Speaking Aged between 21 to 75 years 3 month history of Chronic Idiopathic Urticaria and/or Angioedema Exclusion Criteria: age <21 and >75 years non english speaking systemic lupus erythematosis dysproteinemias thyrotoxicosis vasculitis infection
Sites / Locations
- Alfred Hospital
Outcomes
Primary Outcome Measures
The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale)
Secondary Outcome Measures
The relative use of antihistamines (ie how many, how often)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163839
Brief Title
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
Official Title
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria or Angioedema: A Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bayside Health
4. Oversight
5. Study Description
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.
Detailed Description
The role of dietary pseudoallergens as a trigger for CIU and/or Angioedema is a controversial subject. 'Dietary Pseudoallergy' refers to the mimicking of IgE symptoms (such as rash, itch and swelling) by components of food in the absence of a true IgE mediated response (as diagnosed by RAST and skin prick testing).
The pseudoallergen-free diet excludes a range of naturally occuring chemicals (including salicylates, amines and brewers yeast) in addition to a range of artificial preservatives and additives (for example sulphites and glutamates). The control diet is based on the general dietary guidelines for the management of diabetes (including the principles of healthy eating, low glycemic index choices and a reduced saturated fat intake).
Subjects recruited into the study will have a 3 month history of CIU and/or Angioedema and will be randomly assigned to either the active or control arm of the study in a single blinded fashion. All subjects will be advised to cease antihistamine medication and will receive one-on-one dietary counselling by a Dietitian. The diet to which each subject has been assigned (ie either active or placebo) is to be followed for a 4 week duration. The frequency and severity of CIU and/or Angioedema as well as adherence to the diet are to be measured on both a daily and weekly basis by the subject via the completion of a clinical score card. The results of the score cards will be collated to determine the relative effects of each diet on these conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria, Angioedema
Keywords
Dietary Intervention, Pseudoallergen free diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Dietary Therapy
Primary Outcome Measure Information:
Title
The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale)
Secondary Outcome Measure Information:
Title
The relative use of antihistamines (ie how many, how often)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English Speaking
Aged between 21 to 75 years
3 month history of Chronic Idiopathic Urticaria and/or Angioedema
Exclusion Criteria:
age <21 and >75 years
non english speaking
systemic lupus erythematosis
dysproteinemias
thyrotoxicosis
vasculitis
infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate L Connell, Masters
Phone
0061 3 9276 3063
Email
k.connell@alfred.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Douglass, FRACP MD
Phone
0061 3 9276 3836
Email
j.douglass@alfred.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Connell, Masters
Organizational Affiliation
Alfred Hospital, Melbourne, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate L Connell, Masters
Phone
0061 3 9276 3063
Email
k.connell@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Jo Douglass, FRACP MD
Phone
0061 3 9276 3836
Email
j.douglass@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Kate L Connell, Masters
First Name & Middle Initial & Last Name & Degree
Jo Douglass, FRACP MD
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
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