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临床试验/NCT03475017
NCT03475017已完成不适用

Effects of Curcumin Supplementation in Inflammation, Oxidative Stress and Intestinal Microbiota in Patients With Chronic Kidney Disease

Denise Mafra2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Antioxidants and anti-inflammatory biomarkers

研究概览

简要总结

Many studies have been conducted to identify therapeutic strategies to modulate inflammation and oxidative stress, complications that contribute to the increased morbidity and cardiovascular mortality in patients with chronic kidney disease (CKD). Among several non-pharmacological strategies, the use of bioactive compounds has emerged as a potential approach to reduce these complications in CKD patients. In this context, turmeric/curcumin may have positive consequences in terms of cardiovascular and nephroprotection because of its antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study is the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as inflammation and oxidative stress in CKD patients.

详细描述

This is a longitudinal study of the type randomized crossover, double-blind, placebo-controlled, washout period. We selected 30 patients with CKD in hemodialysis at Clínica Renalcor / RJ (second sample calculation, considering p = 0.05 and test power of 80%). Eligible patients of both genders, previously evaluated and authorized by the medical staff of the clinic, were invited to participate in the research.

The research was carried out after signing the free and informed consent form, according to the standards of the local Research Ethics Committees and required by Resolution 466 of December 12, 2012 (Conselho Nacional de Saúde), based on the guidelines of the Declaration of Helsinki and of the World Medical Association on human research. This project was approved by the Ethics Committee of the Faculty of Medicine / UFF, number: 2.346.933. It is registered with ClinicalTrials.gov under the number NCT 03475017.

Inclusion and exclusion criteria:

Patients with stage 5 CKD (GFR <15 mL / min) on hemodialysis for more than 6 months, aged at least 18 years, and who had arteriovenous fistula (AVF) as vascular access were included in the study. Patients who were pregnant, smokers, antibiotics in the last 3 months, antioxidant supplements and habitual turmeric and / or turmeric intake, besides those with autoimmune and infectious diseases, cancer, hepatic diseases and AIDS were not included in the study.

The food intake was evaluated at the beginning and at the end of the intervention through the 24-h food recall technique. The analysis of total energy intake (kcal/kg), carbohydrates (%), lipids (%), protein (g/kg), phosphorus (mg) and potassium (mg) were estimated using NutWin® software.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Clinical diagnosis of Chronic Kidney Disease
  • Hemodialysis patients for more than 6 months
  • Aged 18 years or older
  • Must be able to swallow tablets

排除标准

  • Patients pregnant
  • Using antibiotics in the last 3 months
  • Using antioxidant supplements in the last 3 months
  • Usual intake of turmeric
  • Usual intake Autoimmune
  • Clinical diagnosis of infectious diseases
  • Clinical diagnosis of Cancer
  • Clinical diagnosis of AIDS

结局指标

主要结局

Antioxidants and anti-inflammatory biomarkers

时间窗: 4 weeks

Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)

Inflammatory biomarkers

时间窗: 4 weeks

Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)

次要结局

未报告次要终点

研究者

发起方
Denise Mafra
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Denise Mafra

Doctor

Universidade Federal Fluminense

研究点 (2)

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