NCT04921163

Children With Aluminium Contact Allergy: Oral Exposure Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: National Allergy Research Center, Denmark · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Contact Dermatitis
• Contact Allergy
• Aluminum Allergy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	sodium aluminium phospate (SALP)	1 pancake daily for 4 days
DIETARY_SUPPLEMENT	Aluminium-free pancake	1 pancake daily for 4 days, without aluminium

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-05-15
• Completion: 2022-06-15
• First posted: 2021-06-10
• Last updated: 2023-03-28

Locations

1 site across 1 country: Denmark