Children With Aluminium Contact Allergy: Oral Exposure Study

NCT04921163 | Completed DMC

• 1 other identifier: H-20060917
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Dermatitis; Contact Allergy; Aluminum Allergy

Keywords

vaccination granuloma; aluminium; contact allergy; exposure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• sleep

  1-7 days

Study Arms (3)

aluminium

ACTIVE COMPARATOR

4-day test periode with intake of aluminium pancakes

Dietary Supplement: sodium aluminium phospate (SALP)

placebo

PLACEBO COMPARATOR

4-day test periode with aluminium-free pancakes

Dietary Supplement: Aluminium-free pancake

second placebo

PLACEBO COMPARATOR

Again a 4-day test periode with aluminium-free pancakes

Dietary Supplement: Aluminium-free pancake

Interventions

sodium aluminium phospate (SALP) DIETARY_SUPPLEMENT

1 pancake daily for 4 days

aluminium

Aluminium-free pancake DIETARY_SUPPLEMENT

1 pancake daily for 4 days, without aluminium

placebo; second placebo

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Allergy Research Center, Denmark: lead

Study Sites (1)

National Allergy Research Centre

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ph.d. student

Model Details: double blinded cross over study

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: June 10, 2021
• Study Start: June 1, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 15, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)