CompletedNot Applicable

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

Denmark9 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Allergic reactions during fish oil provocation.

Timeframe: 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.

Timeframe: 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.

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

Trial details

NCT IDNCT05677074

SponsorUniversity Hospital, Gentofte, Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-24

View on ClinicalTrials.gov More Food Hypersensitivity trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Allergic reactions during fish oil provocation.

Timeframe: 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.

Timeframe: 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.

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