Food HypersensitivityNCT05677074
Do Patients With Fish or Shellfish Allergy Tolerate the Consumption of Fish Oil Supplements? A Clinical Study
A study testing Fish oil, Cod oil and Krill oil in people with Food Hypersensitivity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Hypersensitivity
- What is being tested?
- Fish oil, Cod oil and Krill oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 24 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old)
- Legally competent
- Understands Danish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Food Hypersensitivity
- Being tested
- Fish oil, Cod oil, Krill oil
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
The tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Cod oilDietary supplement
The tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation.
Krill oilDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fish oil; Dietary Supplement: Cod oil; Dietary Supplement: Krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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.
Measured: At baseline
Subjective allergic symptoms during oral provocations
Subjective allergic symptoms (e.g. itchiness, throat irritation) are noted
Measured: 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
Measured: 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
Measured: 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
Measured: Change in blood pressure from baseline in case of allergic reaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jan 2023
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Heise Garvey, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677074
- Sponsor's protocol ID
- H-22056640
- Status last verified
- Apr 2023
- First submitted
- 20 Dec 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie
- ClinicalTrials.gov ID
- NCT05677074
- Acronym / sponsor ID
- H-22056640
- Conditions
- Food Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolerance test of fish oil, cod oil, and krill oil | Experimental | Dietary Supplement: Fish oil, Dietary Supplement: Cod oil, Dietary Supplement: Krill oilAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (≥18 years old)
- Legally competent
- Understands Danish
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilThe tolerance of fish oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation. | Dietary supplement | Tolerance test of fish oil, cod oil, and krill oil |
| Cod oilThe tolerance of cod oil is tested using three methods: skin-prick-test, Basophil Histamine Release Assay, and oral provocation. | Dietary supplement | Tolerance test of fish oil, cod oil, and krill oil |
| Krill oilThe 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). | Dietary supplement | Tolerance test of fish oil, cod oil, and krill oil |
Primary outcome
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.
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.
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.
6 secondary outcomes
Skin-prick-test
Time frame: 15 minutes after the skin-prick-test has been administered.
Basophil Histamine Release Assay
Time frame: At baseline
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).
Blood pressure during oral provocations
Time frame: Change in blood pressure from baseline in case of allergic reaction
Pulse during oral provocations
Time frame: Change in blood pressure from baseline in case of allergic reaction
Peak flow during oral provocations
Time frame: Change in blood pressure from baseline in case of allergic reaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil, Cod oil and Krill oil in people with Food Hypersensitivity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.