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

NCT ID: NCT00163839

Last Updated: 2012-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30

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.

Conditions

Urticaria; Angioedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Dietary Therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayside Health

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Kate Connell, Masters

Role: PRINCIPAL_INVESTIGATOR

Alfred Hospital, Melbourne, Australia

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Central Contacts

Kate L Connell, Masters

Role: CONTACT

k.connell@alfred.org.au

0061 3 9276 3063

Jo Douglass, FRACP MD

Role: CONTACT

j.douglass@alfred.org.au

0061 3 9276 3836

Facility Contacts

Kate L Connell, Masters

Role: primary

k.connell@alfred.org.au

0061 3 9276 3063

Jo Douglass, FRACP MD

Role: backup

j.douglass@alfred.org.au

0061 3 9276 3836

Other Identifiers

Ph: 00613 9276 3063

Identifier Type: -

Identifier Source: secondary_id

30/05

Identifier Type: -

Identifier Source: org_study_id