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临床试验/NCT03683238
NCT03683238已完成不适用

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

Federico II University0 个研究点目标入组 81 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
主要终点
Trimethylamine N-oxide plasma levels

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Trimethylamine N-oxide plasma levels

时间窗: April 2015 to April 2018

ultra high-performance liquid chromatography

Adherence to Mediterranean Diet by Predimed Questionnaire

时间窗: 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

时间窗: 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).

次要结局

  • Vitamin D(April 2015 to April 2018)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Silvia Savastano

Associate Professor

Federico II University

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