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

NCT05677074 | Completed

• 1 other identifier: H-22056640
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Skin-prick-test

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

• Basophil Histamine Release Assay

  At baseline

• Subjective allergic symptoms during oral provocations

  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

  Change in blood pressure from baseline in case of allergic reaction

• Pulse during oral provocations

  Change in blood pressure from baseline in case of allergic reaction

Study Arms (1)

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

EXPERIMENTAL

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; Dietary Supplement: Cod oil; Dietary Supplement: Krill oil

Interventions

Fish oil DIETARY_SUPPLEMENT

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

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

Cod oil DIETARY_SUPPLEMENT

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

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

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Fish Oils; CVD protocol

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

DK (1)