Contact DermatitisNCT04921163
Children With Aluminium Contact Allergy: Oral Exposure Study
A study testing sodium aluminium phospate (SALP) and Aluminium-free pancake in people with Contact Dermatitis and Contact Allergy, run by National Allergy Research Center, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Contact Dermatitis, Contact Allergy, Aluminum Allergy
- What is being tested?
- sodium aluminium phospate (SALP) and Aluminium-free pancake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2021to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Contact Dermatitis, Contact Allergy, Aluminum Allergy
- Being tested
- sodium aluminium phospate (SALP), Aluminium-free pancake
- Keywords
- vaccination granuloma, aluminium, contact allergy, exposure
- Medical subject headings
- Dermatitis, Contact, Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium aluminium phospate (SALP)Dietary supplement
1 pancake daily for 4 days
Aluminium-free pancakeDietary supplement
1 pancake daily for 4 days, without aluminium
| Study group | Role | What they receive |
|---|---|---|
| aluminium | Active comparator | 4-day test periode with intake of aluminium pancakes Receives: Dietary Supplement: sodium aluminium phospate (SALP) |
| placebo | Placebo comparator | 4-day test periode with aluminium-free pancakes Receives: Dietary Supplement: Aluminium-free pancake |
| second placebo | Placebo comparator | Again a 4-day test periode with aluminium-free pancakes Receives: Dietary Supplement: Aluminium-free pancake |
What is being measured
The primary outcome is the main question the study is designed to answer.
granuloma
itch of existing granuloma evaluated on a Visual analogue scale 0-10
Measured: 1-7 days
skin
flare-up of previous patch test area, evaluated on a visual scheme
Measured: 1-7 days
subjective
headache, irritability, stomach ache evaluated on an adapted visual analogue scale 0-10
Measured: 1-7 days
Secondary outcomes (1)
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
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021
- Primary completion15 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double blinded cross over study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Allergy Research Center, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Hoffmann, National Allergy Research Center, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921163
- Sponsor's protocol ID
- H-20060917
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With Aluminium Contact Allergy: Oral Exposure Study (the Pancake Study)
- ClinicalTrials.gov ID
- NCT04921163
- Acronym / sponsor ID
- H-20060917
- Conditions
- Contact Dermatitis, Contact Allergy, Aluminum Allergy
- Keywords
- vaccination granuloma, aluminium, contact allergy, exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Allergy Research Center, DenmarkUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- double blinded cross over study
| Arm | Type | Receives |
|---|---|---|
| aluminium | Active comparator | Dietary Supplement: sodium aluminium phospate (SALP)4-day test periode with intake of aluminium pancakes |
| placebo | Placebo comparator | Dietary Supplement: Aluminium-free pancake4-day test periode with aluminium-free pancakes |
| second placebo | Placebo comparator | Dietary Supplement: Aluminium-free pancakeAgain a 4-day test periode with aluminium-free pancakes |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium aluminium phospate (SALP)1 pancake daily for 4 days | Dietary supplement | aluminium |
| Aluminium-free pancake1 pancake daily for 4 days, without aluminium | Dietary supplement | placebo, second placebo |
Primary outcome
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
1 secondary outcome
sleep
Time frame: 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium aluminium phospate (SALP) and Aluminium-free pancake in people with Contact Dermatitis and Contact Allergy, run by National Allergy Research Center, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
granuloma (time frame: 1-7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.