NCT05677074

Do Patients With Fish or Shellfish Allergy Tolerate the Consumption of Fish Oil Supplements? A Clinical Study

Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to test whether patients with fish or shellfish allergy can ingest different types of fish oil supplements without having an allergic reaction. 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.

Detailed description

The Basophil Histamine Release Assay is a test that indicates whether or not the immune cells of the participant reacts when it comes into contact with the fish oils. 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

• Food Hypersensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish oil	The tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
DIETARY_SUPPLEMENT	Cod oil	The tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
DIETARY_SUPPLEMENT	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).

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2023-01-10
• Last updated: 2023-04-25

Locations

1 site across 1 country: Denmark