1) Objectives:
Main objectives:
Effect of vitamin E supplement on serum systemic and vascular inflammatory markers and lipids in hemodialysis patients
Proprietary objectives:
1- Determining the mean of variations like sex, height, age at baseline, weight, body mass index, total energy, total protein, fiber, total fat, saturated fatty acids, mono and poly unsaturated fatty acids, cholesterol, vitamin E and C in diet, in addition serum triglycerides, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, high sensitive c reactive protein in baseline and the end of the study in both groups of patients ( vitamin E and placebo )
2- The effect of vitamin E in lipid profile ( total cholesterol, triglycerides, low density lipoprotein cholesterol, high density lipoprotein cholesterol levels )
3- The effect of vitamin E on serum systemic and vascular inflammatory markers ( high sensitive c reactive protein, vascular cell adhesion protein 1, intercellular adhesion molecule 1, Interleukin 6 )
4- Determination of serum concentration of Interleukin 6, vascular cell adhesion protein 1, intercellular adhesion molecule 1 and lipid profile at baseline and the end of the study in two hemodialysis patients groups ( vitamin E and placebo )
5- Compare the quality of confounding variables like sex, age, smoking, type of dialysis filter, diabetes, vitamin E and C supplementation, gemfibrozil drug and statin group drugs between both groups of patients
Practical objective:
Find effective therapies with fewer side effects for the control of systemic and vascular inflammatory markers and lipids in hemodialysis patients
2) Design:
- Study groups: one control group and one intervention group
- Trial phase: 2
- Sample size : 44 patients.
- Blinding: Blinding for patients and researchers groups
- randomization: randomized clinical trial, randomization by stratified blocked randomization method.
3) Setting and conduct:
- At the beginning of study, before starting dialysis, blood samples are going to be taken after12 to 14 hours fasting
- In both men and women vitamin E and placebo are going to be given in intervention and control groups respectively for 10 weeks.
- Fill out 24 hours recall questionnaire in 1th, 5th and 10th weeks
- Tacking blood samples again at the end of the study
4) Inclusion criteria:
- Passing at least one year of dialysis
- Dialysis at least twice a week
Exclusion criteria:
- Supplementation with omega3 and antioxidant vitamins, Taking glucocorticoids, non-steroidal anti-inflammatory, thyroxine and warfarin drugs
- Not taking supplements more than 10 percent in any pursuit
5) Intervention:
In both men and women 3 soft gels of 200IU vitamin E in the intervention group and 3 placebo in the control group will be given daily with main meals for 10 weeks
6) Primary outcome measure:
Serum Triglycerides
Total Cholesterol
Low Density Lipoprotein Cholesterol
High Density Lipoprotein Cholesterol
High Sensitive C Reactive Protein
Vascular Cell Adhesion Protein 1
Intercellular Adhesion Molecule 1
Interleukin 6