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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||18 Years and Over|
- - Adult (≥18 years old) - Legally competent.
- - Understands Danish.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Gentofte, Copenhagen|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Gentofte, Hellerup, 2900
Lene H Garvey, MD, PhD