Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163839
Status:
UNKNOWN
Last Update Posted:
2012-02-16
First Post:
2005-09-12
Brief Title:
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria andor Angioedema
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria or Angioedema A Randomised Controlled Study
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor Angioedema
Detailed Description:
The role of dietary pseudoallergens as a trigger for CIU andor 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 andor 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 andor 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
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 andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Ph 00613 9276 3063 | None | None | None |