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

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.

Study Overview

• Status: Completed
• Conditions: Food Hypersensitivity
• Intervention / Treatment: Dietary supplement: Fish oil; Dietary supplement: Cod oil; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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).
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: H-22056640

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No