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

NCT04432896 | Completed DMC

• 1 other identifier: 17042020
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

women; Systemic syndrome; Nickel Allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Nickel free diet and symptoms

  2 years

Study Arms (2)

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.

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.

Other: Dietary protocol

Interventions

Dietary protocol OTHER

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

New dietary protocol; Traditional dietary protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Hypersensitivity; Eczema

Condition Hierarchy (Ancestors)

Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 16, 2020
• Study Start: December 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)