Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Children With Aluminium Contact Allergy: Oral Exposure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04921163
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Stine Hoffmann, National Allergy Research Center, Denmark

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.

Condition or disease Intervention/treatment Phase
Contact Dermatitis Contact Allergy Aluminum Allergy Dietary Supplement: sodium aluminium phospate (SALP) Dietary Supplement: Aluminium-free pancake Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double blinded cross over study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Children With Aluminium Contact Allergy: Oral Exposure Study (the Pancake Study)
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Aluminum

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




Primary Outcome Measures :
  1. granuloma [ Time Frame: 1-7 days ]
    itch of existing granuloma evaluated on a Visual analogue scale 0-10

  2. skin [ Time Frame: 1-7 days ]
    flare-up of previous patch test area, evaluated on a visual scheme

  3. subjective [ Time Frame: 1-7 days ]
    headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10


Secondary Outcome Measures :
  1. sleep [ Time Frame: 1-7 days ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04921163


Contacts
Layout table for location contacts
Contact: Stine Hoffmann, MD 0045 38677309 stine.hoffmann@regionh.dk
Contact: Jeanne Duus Johansen, Prof.

Locations
Layout table for location information
Denmark
National Allergy Research Centre Recruiting
Hellerup, Denmark, 2900
Contact: Stine Hoffmann, MD    0045 38677300      
Sponsors and Collaborators
National Allergy Research Center, Denmark
Layout table for additonal information
Responsible Party: Stine Hoffmann, MD, ph.d. student, National Allergy Research Center, Denmark
ClinicalTrials.gov Identifier: NCT04921163    
Other Study ID Numbers: H-20060917
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stine Hoffmann, National Allergy Research Center, Denmark:
vaccination granuloma
aluminium
contact allergy
exposure
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Hypersensitivity
Skin Diseases
Immune System Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed