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
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: 1. consumption of 220 milliliters of whey drink three times a week, 2. consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week, 3. consumption of 400 milligrams of vitamin E three times a week, 4. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
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,
malnutrition (based on SGA assessment)
Time frame: 2 months (8 weeks)
Malnutrition inflammation score
Time frame: 2 months (8 weeks)
serum interleukin-6
Time frame: 2 months (8 weeks)
serum C-reactive protein
Time frame: 2 months (8 weeks)
serum albumin
Time frame: 2 months (8 weeks)
serum HDL-c
Time frame: 2 months (8 weeks)
serum total cholesterol
Time frame: 2 months (8 weeks)
serum triglyceride
Time frame: 2 months (8 weeks)
serum transferrin
Time frame: 2 months (8 weeks)
serum malondialdehyde
Time frame: 2 months (8 weeks)
BUN (blood urea nitrogen)
Time frame: 2 months (8 weeks)
serum creatinine
Time frame: 2 months (8 weeks)
serum calcium
Time frame: 2 months (8 weeks)
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serum phosphate
Time frame: 2 months (8 weeks)
quality of life
Time frame: 2 months (8 weeks)
weight
Time frame: 2 months (8 weeks)
height
Time frame: 2 months (8 week)
Body mass index
Time frame: 2 months (8 weeks)