We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Bayside Health.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163839
First Posted: September 14, 2005
Last Update Posted: February 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayside Health
  Purpose
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.

Condition Intervention
Urticaria Angioedema Behavioral: Dietary Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria or Angioedema: A Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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)

Estimated Enrollment: 50
Study Start Date: September 2005
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163839


Contacts
Contact: Kate L Connell, Masters 0061 3 9276 3063 k.connell@alfred.org.au
Contact: Jo Douglass, FRACP MD 0061 3 9276 3836 j.douglass@alfred.org.au

Locations
Australia, Victoria
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Kate L Connell, Masters    0061 3 9276 3063    k.connell@alfred.org.au   
Contact: Jo Douglass, FRACP MD    0061 3 9276 3836    j.douglass@alfred.org.au   
Principal Investigator: Kate L Connell, Masters         
Sub-Investigator: Jo Douglass, FRACP MD         
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Kate Connell, Masters Alfred Hospital, Melbourne, Australia
  More Information

ClinicalTrials.gov Identifier: NCT00163839     History of Changes
Other Study ID Numbers: 30/05
Ph: 00613 9276 3063
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: February 16, 2012
Last Verified: September 2005

Keywords provided by Bayside Health:
Dietary Intervention
Pseudoallergen free diet

Additional relevant MeSH terms:
Urticaria
Angioedema
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases