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

September 24, 2018 updated by: Prof. Silvia Savastano, Federico II University

Role of Nutritionist in the Multidisciplinary Approach of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

81

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population consisted of 82 participants, 41 patients with HS and 41 healthy subjects as control group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
April 2015 to April 2018
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).
April 2015 to April 2018
Trimethylamine N-oxide plasma levels
Time Frame: April 2015 to April 2018
ultra high-performance liquid chromatography
April 2015 to April 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D
Time Frame: April 2015 to April 2018
25 OH vitamin D assay for the LIAISON automated analyzer
April 2015 to April 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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