UrticariaNCT00163839
The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria and/or Angioedema
A study testing Dietary Therapy in people with Urticaria and Angioedema, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Urticaria, Angioedema
- What is being tested?
- Dietary Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English Speaking
- Aged between 21 to 75 years
- 3 month history of Chronic Idiopathic Urticaria and/or Angioedema
Who cannot join
- age <21 and >75 years
- non english speaking
- systemic lupus erythematosis
- dysproteinemias
- thyrotoxicosis
- vasculitis
- infection
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred Hospital
Melbourne, Victoria, 3004
Kate L Connell, Masters, 0061 3 9276 3063, k.connell@alfred.org.au
Jo Douglass, FRACP MD, 0061 3 9276 3836, j.douglass@alfred.org.au
About this study
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.
Read the 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
- Being tested
- Dietary Therapy
- Keywords
- Dietary Intervention, Pseudoallergen free diet
- Medical subject headings
- Urticaria, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Kate Connell, Masters, Principal investigator, Alfred Hospital, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163839
- Sponsor's protocol ID
- 30/05
- Other IDs
- Ph: 00613 9276 3063
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 16 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Pseudoallergen-Free Diet in the Treatment of Chronic Idiopathic Urticaria or Angioedema: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00163839
- Acronym / sponsor ID
- 30/05
- Conditions
- Urticaria, Angioedema
- Keywords
- Dietary Intervention, Pseudoallergen free diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Sep 2005
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English Speaking
- Aged between 21 to 75 years
- 3 month history of Chronic Idiopathic Urticaria and/or Angioedema
Key exclusion criteria (7 listed)
- age <21 and >75 years
- non english speaking
- systemic lupus erythematosis
- dysproteinemias
- thyrotoxicosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Therapy | Behavioural | – |
Primary outcome
The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale)
1 secondary outcome
The relative use of antihistamines (ie how many, how often)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Connell, Masters principal investigator
Alfred Hospital, Melbourne, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Therapy in people with Urticaria and Angioedema, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate L Connell, Masters (0061 3 9276 3063, k.connell@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency and severity of CIU and/or angioedema (as determined via a five point rating scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.