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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: whey drink,; Dietary supplement: whey drink fortified with vitaminE; Dietary supplement: vitamin E

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:

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
• Enrollment (Actual): 92
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Mohammad Hassan Eftekhari
• Collaborators: Shiraz University of Medical Sciences

Publications and helpful links

General Publications

• Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: malnutrition; hemodialysis; oxidative stress; whey protein
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Vitamins
• Other Study ID Numbers: 91-6424