Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)

Vitamin D Deficiency Clinical Trial

— NutriHidra  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683238
• Other study ID #: 201/15
• Status: Completed
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Trimethylamine N-oxide plasma levels	ultra high-performance liquid chromatography	April 2015 to April 2018
Secondary	Vitamin D	25 OH vitamin D assay for the LIAISON automated analyzer	April 2015 to April 2018