Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)

NCT03683238 | Completed

• 1 other identifier: 201/15
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Adherence to Mediterranean Diet by Predimed Questionnaire

  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

  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

  ultra high-performance liquid chromatography

  April 2015 to April 2018

Secondary Outcomes (1)

• Vitamin D

  April 2015 to April 2018

Interventions

Mediterranean Diet DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa; Vitamin D Deficiency

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 25, 2018
• Study Start: May 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share