NCT00163839

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

February 16, 2012

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

February 14, 2012

Conditions

UrticariaAngioedema

Keywords

Dietary InterventionPseudoallergen free diet

Outcome Measures

Primary Outcomes (1)

  • The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale)

Secondary Outcomes (1)

  • The relative use of antihistamines (ie how many, how often)

Interventions

Dietary TherapyBEHAVIORAL

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English Speaking
  • Aged between 21 to 75 years
  • month history of Chronic Idiopathic Urticaria and/or Angioedema

You may not qualify if:

  • age \<21 and \>75 years
  • non english speaking
  • systemic lupus erythematosis
  • dysproteinemias
  • thyrotoxicosis
  • vasculitis
  • infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

UrticariaAngioedema

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Kate Connell, Masters

    Alfred Hospital, Melbourne, Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate L Connell, Masters

CONTACT

0061 3 9276 3063k.connell@alfred.org.au

Jo Douglass, FRACP MD

CONTACT

0061 3 9276 3836j.douglass@alfred.org.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Last Updated

February 16, 2012

Record last verified: 2005-09

Locations

AU(1)