Do Patients With Fish or Shellfish Allergy Tolerate the Consumption of Fish Oil Supplements? A Clinical Study
NCT ID: NCT05677074
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2023-01-01
2023-04-24
Brief Summary
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To achieve this, the recruited participants will be asked to:
* provide a blood sample (used for Basophil Histamine Release Assay)
* undergo a skin-prick-test
* partake in multiple oral provocations
These three tests will indicate the likelihood that the participants can consume fish oil supplements without adverse allergic reactions (See the detailed description for an explanation of the tests).
The investigators will test the participants tolerance for three different types fish oil supplements: Fish oil, Cod liver oil, and krill oil.
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Detailed Description
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The skin-prick-test involves the participants having their skin exposed to the fish oils. This is done by first exposing a tiny needle to the given fish oil, and then pricking the needle into the skin on the forearm of the participant. In this way, the immune cells of the skin is exposed to the fish oils. If an allergic reaction occurs, the pricked skin will swell and turn reddish.
During the oral provocation, the participant is asked to ingest small, but increasing, doses of the fish oils over a period of 2 hours. The provocation will end when either an allergic reaction occurs or the participant has ingested a total dose of 5 mL fish oil.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Tolerance test of fish oil, cod oil, and krill oil
All participants will have their tolerance of three different dietary supplements tested (fish oil, cod oil, and krill oil) using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Fish oil
The tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Cod oil
The tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Krill oil
The tolerance of krill oil is tested using two methods: skin-prick-test and Basophil Histamine Release Assay. (We were unable to acquire enough liquid krill oil to perform oral provocation with this supplement).
Interventions
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Fish oil
The tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Cod oil
The tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Krill oil
The tolerance of krill oil is tested using two methods: skin-prick-test and Basophil Histamine Release Assay. (We were unable to acquire enough liquid krill oil to perform oral provocation with this supplement).
Eligibility Criteria
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Inclusion Criteria
* Legally competent
* Understands Danish
Exclusion Criteria
* The presence of severe diseases such as: Cardiovascular disease, asthma, cancer, liver disease, kidney disease, hematological diseases, neurological diseases, dementia, immunological diseases, and endocrine diseases
* Chronic urticaria
* Severe atopic eczema
* Pregnancy and/or breastfeeding
* Participation in another clinical study the previous three months
* Known excessive use of alcohol and/or substance abuse
18 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Lene Heise Garvey
MD, PhD
Locations
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Gentofte Hospital
Gentofte Municipality, Hellerup, Denmark
Countries
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Other Identifiers
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H-22056640
Identifier Type: -
Identifier Source: org_study_id
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