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 because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163839
First received: September 12, 2005
Last updated: February 14, 2012
Last verified: September 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00163839     History of Changes
Other Study ID Numbers: 30/05, Ph: 00613 9276 3063
Study First Received: September 12, 2005
Last Updated: February 14, 2012
Health Authority: Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on October 16, 2014