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Nutritional Status and Hidradenitis Suppurativa (Acne Inversa) (NutriHidra)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03683238
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Information provided by (Responsible Party):
Prof. Silvia Savastano, 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.

Condition or disease Intervention/treatment
Hidradenitis Suppurativa Mediterranean Diet Body Composition Vitamin D Deficiency Trimethylamine N-oxide (TMAO) Dietary Supplement: Mediterranean Diet

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Role of Nutritionist in the Multidisciplinary Approach of Hidradenitis Suppurativa (Acne Inversa)
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • Dietary Supplement: Mediterranean Diet
    We aim to determine the effects of the traditional Mediterranean Diet on Hidradenitis suppurativa

Primary Outcome Measures :
  1. 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)

  2. 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).

  3. Trimethylamine N-oxide plasma levels [ Time Frame: April 2015 to April 2018 ]
    ultra high-performance liquid chromatography

Secondary Outcome Measures :
  1. Vitamin D [ Time Frame: April 2015 to April 2018 ]
    25 OH vitamin D assay for the LIAISON automated analyzer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population consisted of 82 participants, 41 patients with HS and 41 healthy subjects as control group.

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.

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Responsible Party: Prof. Silvia Savastano, Associate Professor, Federico II University Identifier: NCT03683238     History of Changes
Other Study ID Numbers: 201/15
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious