The need for comparison of oral food challenge outcome: the ALlergy Diagnosed by Open oR DOuble blind food challenge (ALDORADO) trial
Completed
- Conditions
- Food allergy10001708
- Registration Number
- NL-OMON50961
- Lead Sponsor
- Martini Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
Children from four till eighteen years old for whom it is recommended to
perform an OFC for a suspected food allergy for cashew nut, hazelnut or peanut
will be eligible for inclusion.
Exclusion Criteria
Patients will be excluded if they use beta blockers and/or prednisolone, if
they suffer from uncontrolled asthma, unstable angina pectoris, fever or if the
patient reported to be pregnant. Patients should also be able to adequately
report the occurrence of possible symptoms and will be excluded if they are not
able to do so (e.g. mentally disabled or not native Dutch speaker).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure will be the difference in the proportion of<br /><br>positive outcomes of the DBPCFC and the open food challenge. Children who had a<br /><br>positive DBPCFC outcome but are not willing to perform the open food challenge<br /><br>will also be defined as a positive open food challenge. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The following secondary outcome measures will be analysed: eliciting dose (i.e.<br /><br>first dose that causes allergic symptoms) and stopping dose (i.e. cumulative<br /><br>total dose that has been eaten), occurrence of symptoms on all challenge days<br /><br>(objective, subjective and severity), percentage of false positive reactions<br /><br>(i.e. the occurrence of allergic symptoms on placebo day in case of DBPCFC) and<br /><br>percentage of successful introduction into diet (if OFC outcome is negative).<br /><br>Furthermore, we keep record of patients for whom an open food challenge might<br /><br>be indicated as first choice to investigate the added value of DBPCFC in these<br /><br>patients.</p><br>