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

• Sponsor: Bayside Health (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00163839
• Collaborator: (none)
• Enrollment: 50
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urticaria; Angioedema	Behavioral: Dietary Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• 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
• Study Start Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale) []

Secondary Outcome Measures

1. The relative use of antihistamines (ie how many, how often) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Alfred Hospital	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

• Bayside Health

Investigators

• Principal Investigator: Kate Connell, Masters, Alfred Hospital, Melbourne, Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00163839
• Other Study ID Numbers: 30/05; Ph: 00613 9276 3063
• First Posted: Sep 14, 2005
• Last Update Posted: Feb 16, 2012
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Dietary Intervention; Pseudoallergen free diet
• Additional relevant MeSH terms: Angioedema; Urticaria; Chronic Urticaria

Study Results

No Results Posted as of Feb 16, 2012