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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Food Hypersensitivity

Treatments: Dietary Supplement: Krill oil; Dietary Supplement: Fish oil; Dietary Supplement: Cod oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05677074

H-22056640

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥18 years old)
• Legally competent
• Understands Danish

Exclusion criteria

• Current use of antihistamine, immunosuppressants, and/or anti-IgE-treatment that cannot be safely terminated during the study period
• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Tolerance test of fish oil, cod oil, and krill oil

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fish oil

Dietary Supplement: Cod oil

Dietary Supplement: Krill oil