Children With Aluminium Contact Allergy: Oral Exposure Study
Primary Purpose
Contact Dermatitis, Contact Allergy, Aluminum Allergy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
sodium aluminium phospate (SALP)
Aluminium-free pancake
Sponsored by
About this trial
This is an interventional basic science trial for Contact Dermatitis focused on measuring vaccination granuloma, aluminium, contact allergy, exposure
Eligibility Criteria
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.
Sites / Locations
- National Allergy Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
aluminium
placebo
second placebo
Arm Description
4-day test periode with intake of aluminium pancakes
4-day test periode with aluminium-free pancakes
Again a 4-day test periode with aluminium-free pancakes
Outcomes
Primary Outcome Measures
granuloma
itch of existing granuloma evaluated on a Visual analogue scale 0-10
skin
flare-up of previous patch test area, evaluated on a visual scheme
subjective
headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04921163
First Posted
January 14, 2021
Last Updated
March 27, 2023
Sponsor
National Allergy Research Center, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04921163
Brief Title
Children With Aluminium Contact Allergy: Oral Exposure Study
Official Title
Children With Aluminium Contact Allergy: Oral Exposure Study (the Pancake Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Allergy Research Center, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis, Contact Allergy, Aluminum Allergy
Keywords
vaccination granuloma, aluminium, contact allergy, exposure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double blinded cross over study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aluminium
Arm Type
Active Comparator
Arm Description
4-day test periode with intake of aluminium pancakes
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
4-day test periode with aluminium-free pancakes
Arm Title
second placebo
Arm Type
Placebo Comparator
Arm Description
Again a 4-day test periode with aluminium-free pancakes
Intervention Type
Dietary Supplement
Intervention Name(s)
sodium aluminium phospate (SALP)
Intervention Description
1 pancake daily for 4 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Aluminium-free pancake
Intervention Description
1 pancake daily for 4 days, without aluminium
Primary Outcome Measure Information:
Title
granuloma
Description
itch of existing granuloma evaluated on a Visual analogue scale 0-10
Time Frame
1-7 days
Title
skin
Description
flare-up of previous patch test area, evaluated on a visual scheme
Time Frame
1-7 days
Title
subjective
Description
headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
sleep
Description
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
Time Frame
1-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Allergy Research Centre
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Children With Aluminium Contact Allergy: Oral Exposure Study
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