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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aluminium | Active Comparator | 4-day test periode with intake of aluminium pancakes |
|
| placebo | Placebo Comparator | 4-day test periode with aluminium-free pancakes |
|
| second placebo | Placebo Comparator | Again a 4-day test periode with aluminium-free pancakes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium aluminium phospate (SALP) | Dietary Supplement | 1 pancake daily for 4 days |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Allergy Research Centre | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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double blinded cross over study
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| Aluminium-free pancake |
| Dietary Supplement |
1 pancake daily for 4 days, without aluminium |
|
| D006968 |
| Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |