Children With Aluminium Contact Allergy: Oral Exposure Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Children With Aluminium Contact Allergy: Oral Exposure Study (the Pancake Study)

Conditions
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Contact Dermatitis, Contact Allergy, Aluminum Allergy

Intervention / Treatment
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* Dietary Supplement: sodium aluminium phospate (SALP)
* Dietary Supplement: Aluminium-free pancake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double blinded cross over study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aluminium<br>4-day test periode with intake of aluminium pancakes | Dietary Supplement: sodium aluminium phospate (SALP)<br>* 1 pancake daily for 4 days<br>|
| Placebo Comparator: placebo<br>4-day test periode with aluminium-free pancakes | Dietary Supplement: Aluminium-free pancake<br>* 1 pancake daily for 4 days, without aluminium<br>|
| Placebo Comparator: second placebo<br>Again a 4-day test periode with aluminium-free pancakes | Dietary Supplement: Aluminium-free pancake<br>* 1 pancake daily for 4 days, without aluminium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| granuloma | itch of existing granuloma evaluated on a Visual analogue scale 0-10 | 1-7 days | 
| skin | flare-up of previous patch test area, evaluated on a visual scheme | 1-7 days | 
| subjective | headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10 | 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep | disturbed sleep evaluated by an activity tracker watch during sleep. The watch records all movements during sleep, and we especially focus on the number of times the child wakes up at night | 1-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination granuloma, aluminium, contact allergy, exposure