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

Food Hypersensitivity Clinical Trial

Official title:

Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677074
• Other study ID #: H-22056640
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 24, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Dietary Supplement:
• 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).

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allergic reactions during fish oil provocation.	Presence of objective allergic symptoms (i.e. hives, redness, respiratory difficulties, and changes in blood pressure) during and two hours after the oral provocation.	At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
Primary	Allergic reactions during cod oil provocation.	Presence of objective allergic symptoms (i.e. hives, redness, respiratory difficulties, and changes in blood pressure) during and two hours after the oral provocation.	At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
Primary	Allergic reactions during krill oil provocation.	Presence of objective allergic symptoms (i.e. hives, redness, respiratory difficulties, and changes in blood pressure) during and two hours after the oral provocation.	At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
Secondary	Skin-prick-test	The size of the hives are measured, if the diameter is >3 mm it is considered a positive result, if the negative and positive control are negative and positive, respectively	15 minutes after the skin-prick-test has been administered.
Secondary	Basophil Histamine Release Assay	The histamine release when in contact with the fish oil is compared with the histamine release when in contact with the positive control: Phorbol 12-myristate 13-acetate (PMA) + ionomycin. A histamine release of >10% compared to the positive control is considered a positive result.	At baseline
Secondary	Subjective allergic symptoms during oral provocations	Subjective allergic symptoms (e.g. itchiness, throat irritation) are noted	At 2 hours after each provocation or at the end of the provocation if terminated early (in case of allergic reaction).
Secondary	Blood pressure during oral provocations	Blood pressure (mmHg) is measured to detect possible changes from baseline,indicating the severity of an allergic reaction	Change in blood pressure from baseline in case of allergic reaction
Secondary	Pulse during oral provocations	Pulse (beats pr. min) is measured to detect possible changes from baseline, indicating the severity of an allergic reaction	Change in blood pressure from baseline in case of allergic reaction
Secondary	Peak flow during oral provocations	Peak flow (liters pr. minute) is measured to detect possible changes from baseline, indicating the severity of an allergic reaction	Change in blood pressure from baseline in case of allergic reaction