Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)

NCT ID: NCT03683238

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-05-31

Brief Summary

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Hidradenitis suppurativa (HS) is a chronic inflammatory, debilitating skin disorder. The exacerbating factors of HS include nutrition and adiposity. The objective of this study was to investigate the relationships between body composition and the adherence to the Mediterranean diet (MD) with the severity of HS in a sample of naïve-treatment patients with HS. In the wake of this evidence, in the study to investigate the relationships between nutritional status, the adherence to the MD, body composition, and the severity of HS in a sample of naïve-treatment patients with HS compared to control group matched for sex, age, and body weight.

Detailed Description

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Conditions

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Hidradenitis Suppurativa Mediterranean Diet Body Composition Vitamin D Deficiency Trimethylamine N-oxide (TMAO)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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Mediterranean Diet

We aim to determine the effects of the traditional Mediterranean Diet on Hidradenitis suppurativa

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy subjects of both gender
* treatment-naïve patients
* had HS diagnosed ≥6 months before study initiation wash out therapy for at least 3 months

Exclusion Criteria

* occasional or current of use of drugs for HS, including topical antibiotics and systemic treatments (such as clindamycin-rifampicin, tetracycline, Rifampicin-moxifloxacin-metronidazole, ertapenem, acitretin, cyclosporine A, dapsone, isotretinoin, biologics;
* hypocaloric diet in the last three months or specific nutritional regimens;
* vitamin/mineral or antioxidant supplementation;
* occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Silvia Savastano

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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201/15

Identifier Type: -

Identifier Source: org_study_id

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