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Children With Aluminium Contact Allergy: Oral Exposure Study

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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

Tracking Information
First Submitted Date  ICMJE January 14, 2021
First Posted Date  ICMJE June 10, 2021
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • granuloma [ Time Frame: 1-7 days ]
    itch of existing granuloma evaluated on a Visual analogue scale 0-10
  • skin [ Time Frame: 1-7 days ]
    flare-up of previous patch test area, evaluated on a visual scheme
  • subjective [ Time Frame: 1-7 days ]
    headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Children With Aluminium Contact Allergy: Oral Exposure Study
Official Title  ICMJE Children With Aluminium Contact Allergy: Oral Exposure Study (the Pancake Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
double blinded cross over study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Contact Dermatitis
  • Contact Allergy
  • Aluminum Allergy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: aluminium
    4-day test periode with intake of aluminium pancakes
    Intervention: Dietary Supplement: sodium aluminium phospate (SALP)
  • Placebo Comparator: placebo
    4-day test periode with aluminium-free pancakes
    Intervention: Dietary Supplement: Aluminium-free pancake
  • Placebo Comparator: second placebo
    Again a 4-day test periode with aluminium-free pancakes
    Intervention: Dietary Supplement: Aluminium-free pancake
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2021)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stine Hoffmann, MD 0045 38677309 stine.hoffmann@regionh.dk
Contact: Jeanne Duus Johansen, Prof.
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04921163
Other Study ID Numbers  ICMJE H-20060917
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stine Hoffmann, National Allergy Research Center, Denmark
Study Sponsor  ICMJE National Allergy Research Center, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Allergy Research Center, Denmark
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP