Tolererer Fiske- og Skaldyrsallergikere Fiskeolietilskud? Et Klinisk Studie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Allergic reactions during fish oil provocation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years old)
- •Legally competent
- •Understands Danish
排除标准
- •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
结局指标
主要结局
Allergic reactions during fish oil provocation.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Blood pressure during oral provocations(Change in blood pressure from baseline in case of allergic reaction)
- Peak flow during oral provocations(Change in blood pressure from baseline in case of allergic reaction)
- Basophil Histamine Release Assay(At baseline)
- Pulse during oral provocations(Change in blood pressure from baseline in case of allergic reaction)
- Skin-prick-test(15 minutes after the skin-prick-test has been administered.)
- 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).)
研究者
Lene Heise Garvey
MD, PhD
University Hospital, Gentofte, Copenhagen