An interventional study of Fish oil and Cod oil in Food Hypersensitivity, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Other
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:
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 9 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
The tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
The tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: At 2 hours after the provocation or at the end of the provocation if terminated early (in case of allergic reaction).
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
Time frame: 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.
Time frame: At baseline
Subjective allergic symptoms during oral provocations
Subjective allergic symptoms (e.g. itchiness, throat irritation) are noted
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change in blood pressure from baseline in case of allergic reaction
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Gentofte, Copenhagen