Children With Aluminium Contact Allergy: Oral Exposure Study (the Pancake Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- granuloma
研究概览
简要总结
Aluminium allergy is predominantly seen in children with small itchy nodules in the skin after vaccinations, so-called granulomas. We want to do an exposure study where aluminium allergic children have to eat aluminium pancakes for a short period of time. The purpose is to investigate whether a worsening of the children's symptoms can be detected, both itching of the granuloma, allergic rash on the skin and also the symptoms that are not measurable, such as headache, stomach ache and general agitation. We also want to examine the concentration of aluminium in the urine, which reflects the absorption of aluminum from the gastrointestinal tract.
详细描述
Parents of aluminium allergic children have reported that children may react with increased itching of their granulomas, skin symptoms in the form of redness, itching and rash, as well as symptoms such as headache, abdominal pain and agitation, by ingesting aluminium-containing foods.
Children are predominantly exposed to aluminium via the diet as they do not yet use aluminium-containing cosmetic products, stomach acid medicines or deodorants. The amount of aluminium in children's diet varies between 0.22-0.90 mg/kg body weight/week, depending on their age. In older children and adults, the intake is less related to the aluminium in infant formula, breakfast cereals and dried fruit, which is consumed more by children than adults.
With this study, we want to create an exposure study where children have to eat pancakes for a limited period of time, where aluminium has been used as baking soda, and for two control periods eat pancakes without aluminium.
Any symptoms occurring during periods could be used to investigate whether children with aluminium allergies generally react after intake of aluminium-containing foods and whether as such it is a consequential condition in some children or whether it is isolated cases. It is a very important issue to clarify with a view to proper advice, both with regard to the possible avoidance of specific foods and in the case of future vaccinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with contact allergies to aluminium, demonstrated by patch tests
- •Activity (itching) of the granulom within the last six months
- •Written consent obtained from all custodians
排除标准
- •a detected food allergy for the remaining products in the pancakes (including wheat flour, eggs and milk)
- •Children treated with topical and/or systemic steroid preparations during and up to 1 week before the start of the study.
- •Children treated with systemic immune suppression during and up to 1 week before the start of the study.
- •Children with kidney or bone disease.
- •Children vaccinated during the study period
- •Treatment with acid neutralising medicines during and up to 1 week before the start of the study
- •Another reason for inability to cooperate, including lack of language skills in Danish or English in parents.
结局指标
主要结局
granuloma
时间窗: 1-7 days
itch of existing granuloma evaluated on a Visual analogue scale 0-10
skin
时间窗: 1-7 days
flare-up of previous patch test area, evaluated on a visual scheme
subjective
时间窗: 1-7 days
headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10
次要结局
- sleep(1-7 days)
研究者
Stine Hoffmann
MD, ph.d. student
National Allergy Research Center, Denmark