NCT01874106已完成不适用
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
Maryam Ekramzadeh, PhD1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年10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
- 120
- 试验地点
- 1
- 主要终点
- Change in serum Albumin
研究概览
简要总结
The purpose of this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission
排除标准
- •Hospitalization because of sepsis or surgery 3 months prior to intervention
- •Cirrhosis
- •Hepatitis virus infection
- •Human Immunodeficiency virus infection
- •Acquired Immunodeficiency Syndrome
- •Active malignancy
- •Active infection
- •Absence of communication
- •Mental Impairment
- •Terminal illness
- •Tube feedings
- •Total parenteral nutrition
- •Pregnancy
- •Not previously seen by a dietitian within 3 months prior to enrollment in the study
- •Not expected to be transplanted within 6 months after the enrollment in the study
- •Absence of malnutrition from a cause other than end stage renal disease(ESRD)
- •Psychiatric conditions, preventing adherence to intervention
- •Consuming immunosuppressive drugs or taking antioxidant supplements including Vitamin E, Vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid,Fish-oil extracts (omega-3 fatty acids), Soy extracts(isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts within 2 months prior to enrollment in the study
结局指标
主要结局
Change in serum Albumin
时间窗: 10 weeks
次要结局
- Change in Subjective Global Assessment (SGA) score(10 weeks)
- Change in Malnutrition-inflammation score(MIS)(10 weeks)
- Change in serum C-Reactive Protein(CRP)(10 weeks)
- Change in serum malondialdehyde(MDA)(10 weeks)
- Change in serum Interleukin-6(IL-6)(10 weeks)
- Change in serum total antioxidant capacity(TAC)(10 weeks)
- Change in serum ferritin(10 weeks)
- Change in serum total iron binding capacity(TIBC)(10 weeks)
- Change in serum urea nitrogen(10 weeks)
- Change in serum creatinine(10 weeks)
- Change in serum phosphorus(10 weeks)
- Change in body fat mass index(BFMI)(10 weeks)
- Change in fat free mass index(FFMI)(10 weeks)
- Change in body cell mass(BCM)(10 weeks)
研究者
Maryam Ekramzadeh, PhD
PhD
Shiraz University of Medical Sciences
研究点 (1)
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