Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921163
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2021-01-14
Brief Title:
Children With Aluminium Contact Allergy Oral Exposure Study
Sponsor:
National Allergy Research Center Denmark
Organization:
National Allergy Research Center Denmark
Study Overview
Official Title:
Children With Aluminium Contact Allergy Oral Exposure Study the Pancake Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childrens 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 childrens diet varies between 022-090 mgkg body weightweek 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
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 childrens diet varies between 022-090 mgkg body weightweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None