Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04921163 |
| Other study ID # |
H-20060917 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
June 15, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
National Allergy Research Center, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
