Nickel SensitivityNCT04432896
Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications
A study testing Dietary protocol in people with Nickel Sensitivity and Allergy, run by University of Pavia at 1 site in Italy.
Trial summary
Background: Nickel is a silvery metal widely used in nature and contained in many foods. Exposure to nickel is responsible for two different types of adverse reactions: Allergic Contact Dermatitis (DAC) and Systemic Nickel Allergy Syndrome (SNAS). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nickel Sensitivity, Allergy, Nickel; Eczema
- What is being tested?
- Dietary protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2018to 1 Dec 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients on first access aged 18 or over;
- nickel phosphate sensitized patients (patch test: ++ or +++);
- monosensitized or polisensitized patients;
- patients with the presence of allergic gastrointestinal symptoms;
- patients negative to diagnostic tests for other allergies;
- signature of informed consent.
Who cannot join
- patients positive for diagnostic tests for other allergies;
- polysensitized patients with additives and preservatives, to exclude any confounding effects;
- patients who have previously received dietary indications for allergy management;
- patients who have been diagnosed with IBD (Irritable Bowel Disease) such as Ulcerative Rectocolitis, Chron's disease, IBS;
- patients in whom a Eating and Nutrition Disorder (DAN) has been diagnosed;
- patients with malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Nickel is a silvery metal widely used in nature and contained in many foods. Exposure to nickel is responsible for two different types of adverse reactions: Allergic Contact Dermatitis (DAC) and Systemic Nickel Allergy Syndrome (SNAS). The latter is characterized by the presence of extra-cutaneous manifestations, in addition to the skin lesions of the DAC, related to the introduction of nickel-containing foods. Therefore, a nutritional intervention is essential to reduce the symptoms of SNAS. Currently in the literature there are no nutritional guidelines on the treatment and management of patients suffering from SNAS and often the indications provided to patients involve the exclusion of groups of foods for prolonged periods, with the consequent risk of developing nutritional deficiencies and malnutrition.
Objectives: to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to Nickel. Provide practical indications to specialist staff in multidisciplinary patient management and make the patient aware of his problem and help him understand how to manage it independently.
Target population: subjects over the age of 18, female, belonging to the U.O. Occupational Medicine Allergology Section at ICS Maugeri of Pavia, with previous diagnosis of Nickel allergy (patch test) and with the presence of gastrointestinal symptoms related to allergy.
Read the detailed description
The primary objective of this intervention study is the evaluation of the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to nickel.
The secondary objective is to:
- verify the correlation between the consumption of a specific food and the onset of gastroenteric symptoms;
- provide a practical indication to the dietician who acts in concert with the figure of the dietician and allergist in the multidisciplinary management of the patient in order to manage and contain the symptoms;
- make the patient aware of his problem and help him understand how to manage it autonomously, from a food point of view, thus promoting a diet as complete and balanced as possible and at the same time reduce the risk of nutritional deficiencies, such as deficits of minerals and vitamins, and the consequent impact on the state of health.
In this experimental study, each patient will be assessed at the baseline time (T0) in which the pathological and physiological history and anthropometric data (weight, height, waist circumference, BMI) will be collected.The patients of the intervention group will be given dietetic indications by the reference dietitian, which must be followed for 8 weeks. In short, the indications provide for an exclusion period (4 weeks). At the end of this phase (T1) one group of foods per week will be reintroduced on the basis of their nickel content.The reintroduction will begin with the group of foods with a lower nickel content and will proceed gradually for a period of 4 weeks (T1a, T1b, T1c, T2). In order to monitor the trend of gastroenteric symptoms, a diary of symptoms will be administered at baseline time (T0) which must be completed for the duration of the study (T1a, T1b, T1c, T2) and which will be delivered and evaluated by the dietician and the reference clinician. To ensure adequate patient support and to monitor compliance with the indications provided, the referring dietitian will have to contact individual patients once a week by telephone or e-mail.
- Conditions
- Nickel Sensitivity, Allergy, Nickel; Eczema, Women, Systemic Syndrome
- Being tested
- Dietary protocol
- Keywords
- women, Systemic syndrome, Nickel Allergy
- Medical subject headings
- Hypersensitivity, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary protocolOther
Dietary protocol to manage symptoms related to Systemic Nickel Allergy Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| New dietary protocol | Experimental | Exclusion of food containing nickel (duration: 4 weeks) + gradual weekly reintroduction of food containing nickel (duration: 4 weeks) under the supervision of a trained dietician who monitors symptoms related to systemic nickel allergy syndrome. Receives: Other: Dietary protocol |
| Traditional dietary protocol | Active comparator | Exclusion of foods containing nickel without monitoring for symptoms related to systemic nickel allergy syndrome by a trained dietician. Receives: Other: Dietary protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
protocol nickel free
to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to nickel.
Throughout the study: therefore during the first phase in which a nickel free diet is followed and during the second phase of gradual reintegration of food containing nickel, patients must fill in a diary of what they eat weekly. The efficacy of dietary indications is evaluated using the visual analog scale. Both the symptoms related to the gastro intestinal system (nausea, diarrhea, vomiting, bloating of the intestine), and those extra intestinal such as headache, itching are evaluated.
Measured: 2 years
Secondary outcomes (1)
Nickel free diet and symptoms
verify the correlation between the consumption of a specific food and the onset of gastroenteric symptoms, using a dietary in wich the patien described what they eat and their specific symptoms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Dec 2018
- Primary completion1 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nickel SensitivityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Principal investigator, Hellas Cena, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432896
- Sponsor's protocol ID
- 17042020
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2020
- Last updated
- 15 Jun 2021
- 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 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications
- ClinicalTrials.gov ID
- NCT04432896
- Acronym / sponsor ID
- 17042020
- Conditions
- Nickel Sensitivity, Allergy, Nickel; Eczema, Women, Systemic Syndrome
- Keywords
- women, Systemic syndrome, Nickel Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 Jun 2020 (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.
Background: Nickel is a silvery metal widely used in nature and contained in many foods. Exposure to nickel is responsible for two different types of adverse reactions: Allergic Contact Dermatitis (DAC) and Systemic Nickel Allergy Syndrome (SNAS). The latter is characterized by the presence of extra-cutaneous manifestations, in addition to the skin lesions of the DAC, related to the introduction of nickel-containing foods. Therefore, a nutritional intervention is essential to reduce the symptoms of SNAS. Currently in the literature there are no nutritional guidelines on the treatment and management of patients suffering from SNAS and often the indications provided to patients involve the exclusion of groups of foods for prolonged periods, with the consequent risk of developing nutritional deficiencies and malnutrition.
Objectives: to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to Nickel. Provide practical indications to specialist staff in multidisciplinary patient management and make the patient aware of his problem and help him understand how to manage it independently.
Target population: subjects over the age of 18, female, belonging to the U.O. Occupational Medicine Allergology Section at ICS Maugeri of Pavia, with previous diagnosis of Nickel allergy (patch test) and with the presence of gastrointestinal symptoms related to allergy.
Detailed description
The primary objective of this intervention study is the evaluation of the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to nickel.
The secondary objective is to:
- verify the correlation between the consumption of a specific food and the onset of gastroenteric symptoms;
- provide a practical indication to the dietician who acts in concert with the figure of the dietician and allergist in the multidisciplinary management of the patient in order to manage and contain the symptoms;
- make the patient aware of his problem and help him understand how to manage it autonomously, from a food point of view, thus promoting a diet as complete and balanced as possible and at the same time reduce the risk of nutritional deficiencies, such as deficits of minerals and vitamins, and the consequent impact on the state of health.
In this experimental study, each patient will be assessed at the baseline time (T0) in which the pathological and physiological history and anthropometric data (weight, height, waist circumference, BMI) will be collected.The patients of the intervention group will be given dietetic indications by the reference dietitian, which must be followed for 8 weeks. In short, the indications provide for an exclusion period (4 weeks). At the end of this phase (T1) one group of foods per week will be reintroduced on the basis of their nickel content.The reintroduction will begin with the group of foods with a lower nickel content and will proceed gradually for a period of 4 weeks (T1a, T1b, T1c, T2). In order to monitor the trend of gastroenteric symptoms, a diary of symptoms will be administered at baseline time (T0) which must be completed for the duration of the study (T1a, T1b, T1c, T2) and which will be delivered and evaluated by the dietician and the reference clinician. To ensure adequate patient support and to monitor compliance with the indications provided, the referring dietitian will have to contact individual patients once a week by telephone or e-mail.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New dietary protocol | Experimental | Other: Dietary protocolExclusion of food containing nickel (duration: 4 weeks) + gradual weekly reintroduction of food containing nickel (duration: 4 weeks) under the supervision of a trained dietician who monitors symptoms related to systemic nickel allergy syndrome. |
| Traditional dietary protocol | Active comparator | Other: Dietary protocolExclusion of foods containing nickel without monitoring for symptoms related to systemic nickel allergy syndrome by a trained dietician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients on first access aged 18 or over;
- nickel phosphate sensitized patients (patch test: ++ or +++);
- monosensitized or polisensitized patients;
- patients with the presence of allergic gastrointestinal symptoms;
- patients negative to diagnostic tests for other allergies;
Key exclusion criteria (6 listed)
- patients positive for diagnostic tests for other allergies;
- polysensitized patients with additives and preservatives, to exclude any confounding effects;
- patients who have previously received dietary indications for allergy management;
- patients who have been diagnosed with IBD (Irritable Bowel Disease) such as Ulcerative Rectocolitis, Chron's disease, IBS;
- patients in whom a Eating and Nutrition Disorder (DAN) has been diagnosed;
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 |
|---|---|---|
| Dietary protocolDietary protocol to manage symptoms related to Systemic Nickel Allergy Syndrome. | Other | New dietary protocol, Traditional dietary protocol |
Primary outcome
protocol nickel free
Time frame: 2 years
to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to nickel. Throughout the study: therefore during the first phase in which a nickel free diet is followed and during the second phase of gradual reintegration of food containing nickel, patients must fill in a diary of what they eat weekly. The efficacy of dietary indications is evaluated using the visual analog scale. Both the symptoms related to the gastro intestinal system (nausea, diarrhea, vomiting, bloating of the intestine), and those extra intestinal such as headache, itching are evaluated.
1 secondary outcome
Nickel free diet and symptoms
Time frame: 2 years
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 15 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Nickel Sensitivity
Recruiting
Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases
Allergic Contact Dermatitis, Metal Allergy
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 Dietary protocol in people with Nickel Sensitivity and Allergy, run by University of Pavia at 1 site in Italy.
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 6 inclusion and 6 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 15 Jun 2021. 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 Italy. 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. 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?
protocol nickel free (time frame: 2 years). 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 15 Jun 2021.