<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432896</url>
  </required_header>
  <id_info>
    <org_study_id>17042020</org_study_id>
    <nct_id>NCT04432896</nct_id>
  </id_info>
  <brief_title>Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications</brief_title>
  <official_title>Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pavia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Nickel is a silvery metal widely used in nature and contained in many foods.&#xD;
      Exposure to nickel is responsible for two different types of adverse reactions: Allergic&#xD;
      Contact Dermatitis (DAC) and Systemic Nickel Allergy Syndrome (SNAS). The latter is&#xD;
      characterized by the presence of extra-cutaneous manifestations, in addition to the skin&#xD;
      lesions of the DAC, related to the introduction of nickel-containing foods. Therefore, a&#xD;
      nutritional intervention is essential to reduce the symptoms of SNAS. Currently in the&#xD;
      literature there are no nutritional guidelines on the treatment and management of patients&#xD;
      suffering from SNAS and often the indications provided to patients involve the exclusion of&#xD;
      groups of foods for prolonged periods, with the consequent risk of developing nutritional&#xD;
      deficiencies and malnutrition.&#xD;
&#xD;
      Objectives: to evaluate the efficacy of dietary indications, developed on the most recent&#xD;
      scientific evidence, useful for the management of the symptoms associated with adverse&#xD;
      reactions to Nickel. Provide practical indications to specialist staff in multidisciplinary&#xD;
      patient management and make the patient aware of his problem and help him understand how to&#xD;
      manage it independently.&#xD;
&#xD;
      Target population: subjects over the age of 18, female, belonging to the U.O. Occupational&#xD;
      Medicine Allergology Section at ICS Maugeri of Pavia, with previous diagnosis of Nickel&#xD;
      allergy (patch test) and with the presence of gastrointestinal symptoms related to allergy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this intervention study is the evaluation of the efficacy of dietary&#xD;
      indications, developed on the most recent scientific evidence, useful for the management of&#xD;
      the symptoms associated with adverse reactions to nickel.&#xD;
&#xD;
      The secondary objective is to:&#xD;
&#xD;
        -  verify the correlation between the consumption of a specific food and the onset of&#xD;
           gastroenteric symptoms;&#xD;
&#xD;
        -  provide a practical indication to the dietician who acts in concert with the figure of&#xD;
           the dietician and allergist in the multidisciplinary management of the patient in order&#xD;
           to manage and contain the symptoms;&#xD;
&#xD;
        -  make the patient aware of his problem and help him understand how to manage it&#xD;
           autonomously, from a food point of view, thus promoting a diet as complete and balanced&#xD;
           as possible and at the same time reduce the risk of nutritional deficiencies, such as&#xD;
           deficits of minerals and vitamins, and the consequent impact on the state of health.&#xD;
&#xD;
      In this experimental study, each patient will be assessed at the baseline time (T0) in which&#xD;
      the pathological and physiological history and anthropometric data (weight, height, waist&#xD;
      circumference, BMI) will be collected.The patients of the intervention group will be given&#xD;
      dietetic indications by the reference dietitian, which must be followed for 8 weeks. In&#xD;
      short, the indications provide for an exclusion period (4 weeks). At the end of this phase&#xD;
      (T1) one group of foods per week will be reintroduced on the basis of their nickel&#xD;
      content.The reintroduction will begin with the group of foods with a lower nickel content and&#xD;
      will proceed gradually for a period of 4 weeks (T1a, T1b, T1c, T2). In order to monitor the&#xD;
      trend of gastroenteric symptoms, a diary of symptoms will be administered at baseline time&#xD;
      (T0) which must be completed for the duration of the study (T1a, T1b, T1c, T2) and which will&#xD;
      be delivered and evaluated by the dietician and the reference clinician. To ensure adequate&#xD;
      patient support and to monitor compliance with the indications provided, the referring&#xD;
      dietitian will have to contact individual patients once a week by telephone or e-mail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>protocol nickel free</measure>
    <time_frame>2 years</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nickel free diet and symptoms</measure>
    <time_frame>2 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Nickel Sensitivity</condition>
  <condition>Allergy</condition>
  <condition>Nickel; Eczema</condition>
  <condition>Women</condition>
  <condition>Systemic Syndrome</condition>
  <arm_group>
    <arm_group_label>New dietary protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional dietary protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exclusion of foods containing nickel without monitoring for symptoms related to systemic nickel allergy syndrome by a trained dietician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary protocol</intervention_name>
    <description>Dietary protocol to manage symptoms related to Systemic Nickel Allergy Syndrome.</description>
    <arm_group_label>New dietary protocol</arm_group_label>
    <arm_group_label>Traditional dietary protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients on first access aged 18 or over;&#xD;
&#xD;
          -  nickel phosphate sensitized patients (patch test: ++ or +++);&#xD;
&#xD;
          -  monosensitized or polisensitized patients;&#xD;
&#xD;
          -  patients with the presence of allergic gastrointestinal symptoms;&#xD;
&#xD;
          -  patients negative to diagnostic tests for other allergies;&#xD;
&#xD;
          -  signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients positive for diagnostic tests for other allergies;&#xD;
&#xD;
          -  polysensitized patients with additives and preservatives, to exclude any confounding&#xD;
             effects;&#xD;
&#xD;
          -  patients who have previously received dietary indications for allergy management;&#xD;
&#xD;
          -  patients who have been diagnosed with IBD (Irritable Bowel Disease) such as Ulcerative&#xD;
             Rectocolitis, Chron's disease, IBS;&#xD;
&#xD;
          -  patients in whom a Eating and Nutrition Disorder (DAN) has been diagnosed;&#xD;
&#xD;
          -  patients with malignancies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istituti Clinici Scientifici Maugeri SpA</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pavia</investigator_affiliation>
    <investigator_full_name>Hellas Cena</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <keyword>women</keyword>
  <keyword>Systemic syndrome</keyword>
  <keyword>Nickel Allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432896
org study id: 17042020
nct id: NCT04432896
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: protocol nickel free
time frame: 2 years
description: 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.
measure: Nickel free diet and symptoms
time frame: 2 years
description: 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
arm group label: New dietary protocol
arm group type: Experimental
description: 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.
arm group label: Traditional dietary protocol
arm group type: Active Comparator
description: Exclusion of foods containing nickel without monitoring for symptoms related to systemic nickel allergy syndrome by a trained dietician.
intervention type: Other
intervention name: Dietary protocol
description: Dietary protocol to manage symptoms related to Systemic Nickel Allergy Syndrome.
arm group label: New dietary protocol
arm group label: Traditional dietary protocol
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Pavia
investigator full name: Hellas Cena
investigator title: Prof
mesh term: Hypersensitivity
mesh term: Syndrome
sharing ipd: No