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Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications

NCT04432896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-06-15

No results posted yet for this study

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). 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.

Conditions

  • Nickel Sensitivity
  • Allergy
  • Nickel; Eczema
  • Women
  • Systemic Syndrome

Interventions

OTHER

Dietary protocol

Dietary protocol to manage symptoms related to Systemic Nickel Allergy Syndrome.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    collaborator OTHER

  • University of Pavia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-11-01
Completion
2020-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04432896 on ClinicalTrials.gov