Quality of Life in Systemic Nickel Allergy Syndrome

NCT03731494 | Completed

• 1 other identifier: 1377/15 (13939/14)
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline index at 12 months

Secondary Outcomes (1)

• Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2)

  Baseline.

Study Arms (1)

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.

Biological: Nickel oral hyposensitization treatment

Interventions

Nickel oral hyposensitization treatment BIOLOGICAL

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.

Also known as: NiOHT - TIO Nickel

Nickel oral hyposensitization treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Roma, 00168, Italy

Location

Study Officials

• Eleonora Nucera, MD,Prof

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Antonio Gasbarrini, MD,Prof

  Catholic University of Sacred Heart

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: March 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: May 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)