The need for comparison of oral food challenge outcomes: the ALlergy Diagnosed by Open oR Double blind food challenge (ALDORADO) trial
- Conditions
- Food allergy
- Registration Number
- NL-OMON27959
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
Children aged 4-18 years who visit our paediatric allergy centre of the Martini Hospital and who are recommended to perform an OFC for a suspected food allergy for cashew nut, hazelnut or peanut.
Exclusion Criteria
- children younger than the age of four years
- patient uses beta blockers and/or prednisolone
- patient suffers from uncontrolled asthma, unstable angina pectoris or fever
- patient reports to be pregnant
- patient is unable to adequately report the occurrence of possible symptoms (e.g. mentally disabled or not native Dutch speaker)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the difference in the proportion of positive outcomes of the DBPCFC and the open food challenge.
- Secondary Outcome Measures
Name Time Method The following secondary outcome measures will be analysed: eliciting dose (i.e. first dose that causes allergic symptoms) and stopping dose (i.e. cumulative total dose that has been eaten), occurrence and severity of symptoms on all challenge days as well as the percentage of false positive reactions (i.e. the occurrence of allergic symptoms on placebo day in case of DBPCFC).