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NCT Number: NCT05677074

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

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.

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Key information

Conditions

Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

The tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.

Cod oil

Dietary Supplement

The tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.

Krill oil

Dietary Supplement

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).

Primary outcomes

  1. Allergic reactions during fish oil provocation.

    Time frame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).

    Presence of objective allergic symptoms (i.e. hives, redness, respiratory difficulties, and changes in blood pressure) during and two hours after the oral provocation.

  2. Allergic reactions during cod oil provocation.

    Time frame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).

    Presence of objective allergic symptoms (i.e. hives, redness, respiratory difficulties, and changes in blood pressure) during and two hours after the oral provocation.

  3. Allergic reactions during krill oil provocation.

    Time frame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).

    Presence of objective allergic symptoms (i.e. hives, redness, respiratory difficulties, and changes in blood pressure) during and two hours after the oral provocation.

Secondary outcomes

  1. Skin-prick-test

    Time frame: 15 minutes after the skin-prick-test has been administered.

    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

  2. Basophil Histamine Release Assay

    Time frame: At baseline

    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.

  3. Subjective allergic symptoms during oral provocations

    Time frame: At 2 hours after each provocation or at the end of the provocation if terminated early (in case of allergic reaction).

    Subjective allergic symptoms (e.g. itchiness, throat irritation) are noted

  4. Blood pressure during oral provocations

    Time frame: Change in blood pressure from baseline in case of allergic reaction

    Blood pressure (mmHg) is measured to detect possible changes from baseline,indicating the severity of an allergic reaction

  5. Pulse during oral provocations

    Time frame: Change in blood pressure from baseline in case of allergic reaction

    Pulse (beats pr. min) is measured to detect possible changes from baseline, indicating the severity of an allergic reaction

  6. Peak flow during oral provocations

    Time frame: Change in blood pressure from baseline in case of allergic reaction

    Peak flow (liters pr. minute) is measured to detect possible changes from baseline, indicating the severity of an allergic reaction

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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