Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)

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.

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Key information

Conditions

Hidradenitis Suppurativa Avitaminosis Bacterial Infections Bacterial Infections and Mycoses Body Composition Deficiency Diseases Hidradenitis Infections Malnutrition Mediterranean Diet Nutrition Disorders Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases Trimethylamine N-oxide (TMAO) Vitamin D Deficiency

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean diet

Dietary Supplement

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

Primary outcomes

Adherence to Mediterranean Diet by Predimed Questionnaire

Time frame: April 2015 to April 2018

Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (≤5, low adherence, 6-9, average adherence and ≥10 points, high adherence)
Phase angle

Time frame: April 2015 to April 2018

Phase angle was performed using a BIA phase-sensitive system by experienced observers (an 800-µA current at a frequency single-frequency of 50 kHz BIA 101 RJL, Akern Bioresearch, Florence, Italy).
Trimethylamine N-oxide plasma levels

Time frame: April 2015 to April 2018

ultra high-performance liquid chromatography

Secondary outcomes

Vitamin D

Time frame: April 2015 to April 2018

25 OH vitamin D assay for the LIAISON automated analyzer

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Role of Nutritionist in the Multidisciplinary Approach of Hidradenitis Suppurativa (Acne Inversa)

Acronym: NutriHidra

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Sep 25, 2018
Registry last updated: Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed