MedTrace Logo

Children With Aluminium Contact Allergy: Oral Exposure Study

NCT04921163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-03-28

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

sodium aluminium phospate (SALP)

1 pancake daily for 4 days

DIETARY_SUPPLEMENT

Aluminium-free pancake

1 pancake daily for 4 days, without aluminium

Sponsors & Collaborators

  • National Allergy Research Center, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-05-15
Completion
2022-06-15

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921163 on ClinicalTrials.gov