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

Sponsor

Mohammad Hassan Eftekhari (Other)

Overall Status

Completed

CT.gov ID

NCT02163070

Collaborator

Shiraz University of Medical Sciences (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Dietary Supplement: whey drink, Dietary Supplement: whey drink fortified with vitaminE Dietary Supplement: vitamin E	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

malnutrition (based on SGA assessment) [2 months (8 weeks)]
Malnutrition inflammation score [2 months (8 weeks)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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