Children With Aluminium Contact Allergy: Oral Exposure Study

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

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.

Study Overview

• Status: Completed
• Conditions: Contact Dermatitis; Contact Allergy; Aluminum Allergy
• Intervention / Treatment: Dietary supplement: sodium aluminium phospate (SALP); Dietary supplement: Aluminium-free pancake

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stine Hoffmann, MD; Phone Number: 0045 38677309; Email: stine.hoffmann@regionh.dk
• Study Contact Backup: Name: Jeanne Duus Johansen, Prof.

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • National Allergy Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aluminium; 4-day test periode with intake of aluminium pancakes	Dietary supplement: sodium aluminium phospate (SALP); 1 pancake daily for 4 days
Placebo Comparator: placebo; 4-day test periode with aluminium-free pancakes	Dietary supplement: Aluminium-free pancake; 1 pancake daily for 4 days, without aluminium
Placebo Comparator: second placebo; Again a 4-day test periode with aluminium-free pancakes	Dietary supplement: Aluminium-free pancake; 1 pancake daily for 4 days, without aluminium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Allergy Research Center, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: exposure; vaccination granuloma; aluminium; contact allergy
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: H-20060917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No