Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)

Completed

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

• Registration Number: NCT03683238
• Lead Sponsor: Federico II University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2018-04
• Study Completion: 2018-05
• Study First Submitted: 2018-07-10
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Study First Posted: 2018-09-25
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trimethylamine N-oxide plasma levels	April 2015 to April 2018	ultra high-performance liquid chromatography
Adherence to Mediterranean Diet by Predimed Questionnaire	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	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).

Secondary Outcome Measures

Name	Time	Method
Vitamin D	April 2015 to April 2018	25 OH vitamin D assay for the LIAISON automated analyzer