Effects of Dietary Supplementation Using Palm Tocotrienols in Chronic Hemodialysis (PATCH) Patients - A Multicenter Study Evaluating Markers of Inflammation, Oxidative Stress and Blood Lipids
试验速览
- 阶段
- 不适用
- 入组人数
- 336
- 试验地点
- 8
- 主要终点
- Improvement in inflammatory marker based on the mean change from baseline to 12 months.
研究概览
简要总结
This study aims to determine if tocotrienol rich fraction (TRF) supplementation can improve markers of inflammation, oxidative stress and blood lipids in Malaysian hemodialysis (HD) patients.
详细描述
This study is a multi-centered, randomized, double blind, placebo-controlled trial where a total of 400 HD patients (200 supplemented; 200 control) will be recruited from government and private settings. Subjects will be randomized to either the intervention or control group. The intervention group will receive TRF (300 mg), daily for 12 months while the control group will only receive placebo, daily for 12 months. In addition, both groups will receive standard dietary counseling to ensure compliance to medical nutrition therapy guidelines for dialysis patients.
Patients who consented will be first subjected to a screening for identification of eligible subjects. The screening will involve basic anthropometry measures (height, weight, BMI), routine biochemistry result obtained from medical record, assessment of nutritional status and dietary evaluation. About 15ml of pre-dialysis blood will be collected by respective nurses for additional laboratory parameters (hsCRP, atherogenic profile and other inflammatory markers).
Patients who fulfill the inclusion criteria will be randomized to either control or intervention group. During the 12 months of treatment period, patients in both control and intervention groups will be assessed at baseline and 3-monthly intervals for laboratory results, medical condition, hospitalizations, nutritional status, dietary intake and compliance towards supplementation (intervention group only). A final measurement will be taken 3 months after study completion as a post follow up assessment upon cessation of supplementation. In all, patient data will be generated at 6 time points.
(A similar study, following a similar protocol and using the same study design and intervention will recruit 400 patients total (200 for each group) in Michigan, USA).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided consent and comply to study protocol
- •Undergoing HD treatment thrice-weekly for > 3 months
- •Adequately dialyzed (Kt/V> 1.2 or urea reduction ratio (URR) of 65%) and hsCRP level <20 mg/dL.
排除标准
- •Participated in another clinical trial involving an investigational product in the past 12 weeks preceding enrolment.
- •Planned for kidney transplant over the study duration.
- •Intake of vitamin E-containing supplements (>60 IU/day) 30 days preceding enrolment.
- •Intake of anti-inflammatory medication except aspirin <325 mg/day in the past 30 days preceding enrollment.
- •Female patients who are pregnant, lactating or planning a pregnancy during the course of the trial.
- •Poor adherence to HD or medical treatment
- •Patient with temporary catheter for dialysis access at baseline, or patients receiving graft/fistula within the 6-month study period.
- •History of hospitalizations (>2 times within the past 90 days or one hospitalization within the 30 days) preceding enrollment.
- •Receiving nutritional support ( via enteral and intra-venous route).
- •Diagnosed with HIV/AIDS and/or on the anti-HIV therapy
- •Receiving active treatment for cancer (excluding basal cell carcinoma of the skin).
- •Patients with Hepatitis B or C.
- •Any other significant disease or disorder where in the opinion of the respective nephrologist may affect the end results of this study
- •Patients with a known allergy towards fish.
结局指标
主要结局
Improvement in inflammatory marker based on the mean change from baseline to 12 months.
时间窗: Baseline to 12 months
Changes in biochemistry marker namely hsCRP (mg/dL)
次要结局
- Changes in anthropometry measures(Baseline to 12 months)
- Changes in restless leg syndrome scoring(Baseline to 12 months)
- Changes in muscle strength(Baseline to 12 months)
- Changes in qualify of life (QOL)(Baseline to 12 months)
- Changes in rate of hospitalisation(Baseline to 12 months)
- Changes in metabolomics analyses(Baseline to 12 months)
- Changes in plasma lipids(Baseline to 12 months)
- Changes in body composition(Baseline to 12 months)
- Changes in dietary intake(Baseline to 12 months)
- Changes in nutritional status(Baseline to 12 months)
- Changes in biochemistry parameters(Baseline to 12 months)
研究者
Associate Professor Dr Tilakavati Karupaiah
Associate Professor
National University of Malaysia