Systemic Nickel Allergy SyndromeNCT03731494
Quality of Life in Systemic Nickel Allergy Syndrome
An observational study of Systemic Nickel Allergy Syndrome and Quality of Life, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Nickel Allergy Syndrome, Quality of Life
- What is being tested?
- Nickel oral hyposensitization treatment
- Type of treatment
- Pill or oral medicine
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to 30 May 2019
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Researchers enrol patients suffer from Systemic Nickel Allergy Syndrome (SNAS), condition characterised by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Nickel-rich foods, especially vegetables.
Who may be able to join
- history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),
- positive Ni-patch test,
- clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,
- positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),
- written informed consent.
Who cannot join
- age < 18 years and > 65 years,
- other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth,
- diabetes mellitus,
- hepatic, renal or cardiac dysfunction,
- thyroid disease or tumor,
- concomitant treatment with steroids and/or antihistamines in the previous 4 weeks, pregnancy, lactation,
- smoking, abuse of alcohol, coffee, tea, and cola intake,
- refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life Assessment Before and After Hyposensitization Treatment in Systemic Nickel Allergy Syndrome
This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS).
Read the detailed description
Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.
It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.
Although a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.
- Conditions
- Systemic Nickel Allergy Syndrome, Quality of Life
- Being tested
- Nickel oral hyposensitization treatment
- Keywords
- Nickel allergy, Systemic nickel allergy syndrome, Health-related quality of life, Nickel oral hyposensitizing treatment, Diet, Short-Form 36-Item Health Survey, Psychological General Well Being Index, Minnesota Multiphasic Personality Inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nickel oral hyposensitization treatmentBiological
Also called NiOHT - TIO Nickel
Nickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected.
| Study group | Role | What they receive |
|---|---|---|
| Nickel oral hyposensitization treatment | The patients take capsules at different doses in nickel content until reaching the maximum dose of 1.5 mcg per week for a total of 12 months. Receives: Biological: Nickel oral hyposensitization treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL: Short-Form 36-Item Health Survey (SF-36v2)
Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively.
Measured: Change from baseline index at 12 months
QoL: Psychological General Well Being Index (PGWBI)
The PGWBI consists of 22 questions, which deal with six factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment.The response format is graded 1-6 (i.e. total range 22-132), with the highest value corresponding to optimal well-being.
Measured: Change from baseline index at 12 months
Secondary outcomes (1)
Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2)
The MMPI-2 questionnaire containing 567 items with 2 choices of answer ("true" or "false") in order to assess the main structural features of personality and emotional disorders.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study startMar 2015
- Primary completion30 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Nickel Allergy SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Nucera, Catholic University of the Sacred Heart
- Investigators
- Eleonora Nucera, MD,Prof, Principal investigator, Catholic University of Sacred HeartAntonio Gasbarrini, MD,Prof, Study director, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731494
- Sponsor's protocol ID
- 1377/15 (13939/14)
- Status last verified
- Feb 2020
- First submitted
- 2 Nov 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment Before and After Hyposensitization Treatment in Systemic Nickel Allergy Syndrome
- ClinicalTrials.gov ID
- NCT03731494
- Acronym / sponsor ID
- 1377/15 (13939/14)
- Conditions
- Systemic Nickel Allergy Syndrome, Quality of Life
- Keywords
- Nickel allergy, Systemic nickel allergy syndrome, Health-related quality of life, Nickel oral hyposensitizing treatment, Diet, Short-Form 36-Item Health Survey, Psychological General Well Being Index, Minnesota Multiphasic Personality Inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 6 Nov 2018 (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.
This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS).
Detailed description
Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.
It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.
Although a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nickel oral hyposensitization treatment | – | Biological: Nickel oral hyposensitization treatmentThe patients take capsules at different doses in nickel content until reaching the maximum dose of 1.5 mcg per week for a total of 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Researchers enrol patients suffer from Systemic Nickel Allergy Syndrome (SNAS), condition characterised by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Nickel-rich foods, especially vegetables.
Key inclusion criteria (5 listed)
- history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),
- positive Ni-patch test,
- clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,
- positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),
- written informed consent.
Key exclusion criteria (8 listed)
- age < 18 years and > 65 years,
- other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth,
- diabetes mellitus,
- hepatic, renal or cardiac dysfunction,
- thyroid disease or tumor,
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 |
|---|---|---|
| Nickel oral hyposensitization treatmentAlso: NiOHT - TIO NickelNickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected. | Biological | Nickel oral hyposensitization treatment |
Primary outcome
QoL: Short-Form 36-Item Health Survey (SF-36v2)
Time frame: Change from baseline index at 12 months
Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively.
QoL: Psychological General Well Being Index (PGWBI)
Time frame: Change from baseline index at 12 months
The PGWBI consists of 22 questions, which deal with six factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment.The response format is graded 1-6 (i.e. total range 22-132), with the highest value corresponding to optimal well-being.
1 secondary outcome
Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2)
Time frame: Baseline.
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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.
Eleonora Nucera, MD,Prof principal investigator
Catholic University of Sacred Heart
Antonio Gasbarrini, MD,Prof study director
Catholic University of Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Nickel Allergy Syndrome and Quality of Life, run by Catholic University of the Sacred Heart 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 5 inclusion and 8 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 5 Feb 2020. 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?
QoL: Short-Form 36-Item Health Survey (SF-36v2) (time frame: Change from baseline index at 12 months). The study lists 2 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 5 Feb 2020.