Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 主要终点
- malnutrition (based on SGA assessment)
研究概览
简要总结
The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients
详细描述
The aim of this interventional study was to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients. 92 hemodialysis patients were selected for the study. Inclusion criteria included: mean age of 17-65 years old; having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment; being dialyzed at least 2 times a week for 3 months. Exclusion criteria included: hospitalization in the last month; active infection; using immunosuppressant drugs or multi-vitamins; pregnancy. The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.Informed consent were signed by all of them for participating in the study. Weight and height of the patients were recorded for BMI (body mass index) calculation. Then, all of the patients were assigned into 4 groups:
- consumption of 220 milliliters of whey drink three times a week,
- consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
- consumption of 400 milligrams of vitamin E three times a week,
- control group: no intervention. Patients were followed for 2 months. At the beginning and the end of the 2-month intervention period, 10 milliliters of blood were taken from all of the patients and nutritional status of the patients were assessed as the primary outcome. Serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and lipoproteins were also measured. SGA, MIS and SF-12 questionnaires were filled for all of the patients at the beginning and the end of the study.
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
- 17 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mean age of 17-65 years old;
- •having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment;
- •be dialyzed at least 2 times a week for 3 months
排除标准
- •hospitalization in the last month;
- •active infection;
- •using immunosuppressant drugs or multi-vitamins;
- •pregnancy, consuming whey or soy products
结局指标
主要结局
malnutrition (based on SGA assessment)
时间窗: 2 months (8 weeks)
Malnutrition inflammation score
时间窗: 2 months (8 weeks)
次要结局
- serum calcium(2 months (8 weeks))
- serum interleukin-6(2 months (8 weeks))
- serum C-reactive protein(2 months (8 weeks))
- serum albumin(2 months (8 weeks))
- serum creatinine(2 months (8 weeks))
- serum malondialdehyde(2 months (8 weeks))
- BUN (blood urea nitrogen)(2 months (8 weeks))
- serum phosphate(2 months (8 weeks))
- quality of life(2 months (8 weeks))
- Body mass index(2 months (8 weeks))
- serum transferrin(2 months (8 weeks))
- weight(2 months (8 weeks))
- serum HDL-c(2 months (8 weeks))
- serum total cholesterol(2 months (8 weeks))
- serum triglyceride(2 months (8 weeks))
- height(2 months (8 week))
研究者
Mohammad Hassan Eftekhari
professor. PhD
Shiraz University of Medical Sciences