Urticaria Clinical Trial
Official title:
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria or Angioedema: A Randomised Controlled Study
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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