Children With Aluminium Contact Allergy: Oral Exposure Study

Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921163
• Other study ID #: H-20060917
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aluminum Allergy
• Contact Allergy
• Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact
• Hypersensitivity

Intervention

Dietary Supplement:
• sodium aluminium phospate (SALP)
1 pancake daily for 4 days
• Aluminium-free pancake
1 pancake daily for 4 days, without aluminium

Locations

Country	Name	City	State
Denmark	National Allergy Research Centre	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
National Allergy Research Center, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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