NCT00655525已完成2 期
Omega-3 Fatty Acid Administration in Dialysis Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
研究概览
简要总结
The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.
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
- 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
- 否
入选标准
- •Patients on CHD for more than 6 months;
- •Ability to read and sign the consent form;
- •Have acceptable dialysis adequacy (Kt/V > 1.2);
- •Use biocompatible hemodialysis membrane;
- •Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
- •Signs of chronic inflammation (average CRP of ≥ 5 mg/L for 3 consecutive measurements)
排除标准
- •Pregnancy;
- •Intolerance to the study medication;
- •Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- •Diabetes mellitus on insulin therapy;
- •Hospitalization within 1 month prior to the study;
- •Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 500 ml/min);
- •Patients receiving steroids (> 5 mg/day) and/or other immunosuppressive agents;
- •Life-expectancy less than 6 months;
- •Age less than 18 years old;
- •Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
- •Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).
结局指标
主要结局
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
时间窗: 3 months
A decrease in muscle protein breakdown
时间窗: 3 months
次要结局
- A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)(3 months)
- An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)(3 months)
研究者
Alp Ikizler
Professor
Vanderbilt University
研究点 (2)
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