Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Dietary Supplement: whey drink,
* Dietary Supplement: whey drink fortified with vitaminE
* Dietary Supplement: vitamin E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: hospitalization in the last month; active infection; using immunosuppressant drugs or multi-vitamins; pregnancy, consuming whey or soy products

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whey drink<br>consumption of 220 milliliters of whey drink three times a week, | Dietary Supplement: whey drink,<br>* consumption of 220 milliliters of whey drink three times a week,<br>|
| Experimental: whey drink fortified with vitaminE<br>consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week, | Dietary Supplement: whey drink fortified with vitaminE<br>* consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,<br>|
| Experimental: vitaminE<br>consumption of 400 milligrams of vitamin E three times a week, | Dietary Supplement: vitamin E<br>* consumption of 400 milligrams of vitamin E three times a week,<br>|
| No Intervention: D- control<br>control group: no intervention, | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malnutrition (based on SGA assessment) |  | 2 months (8 weeks) | 
| Malnutrition inflammation score |  | 2 months (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum interleukin-6 |  | 2 months (8 weeks) | 
| serum C-reactive protein |  | 2 months (8 weeks) | 
| serum albumin |  | 2 months (8 weeks) | 
| serum HDL-c |  | 2 months (8 weeks) | 
| serum total cholesterol |  | 2 months (8 weeks) | 
| serum triglyceride |  | 2 months (8 weeks) | 
| serum transferrin |  | 2 months (8 weeks) | 
| serum malondialdehyde |  | 2 months (8 weeks) | 
| BUN (blood urea nitrogen) |  | 2 months (8 weeks) | 
| serum creatinine |  | 2 months (8 weeks) | 
| serum calcium |  | 2 months (8 weeks) | 
| serum phosphate |  | 2 months (8 weeks) | 
| quality of life |  | 2 months (8 weeks) | 
| weight |  | 2 months (8 weeks) | 
| height |  | 2 months (8 week) | 
| Body mass index |  | 2 months (8 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
whey protein, malnutrition, oxidative stress, hemodialysis