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

Overview

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

Full Title of Study: “Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

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.

Interventions

  • Dietary Supplement: whey drink,
    • consumption of 220 milliliters of whey drink 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,
  • Dietary Supplement: vitamin E
    • consumption of 400 milligrams of vitamin E three times a week,

Arms, Groups and Cohorts

  • Experimental: 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,
  • Experimental: vitaminE
    • consumption of 400 milligrams of vitamin E three times a week,
  • No Intervention: D- control
    • control group: no intervention,

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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)
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mohammad Hassan Eftekhari
  • Collaborator
    • Shiraz University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Mohammad Hassan Eftekhari, professor. PhD – Shiraz University of Medical Sciences
  • Overall Official(s)
    • Mohammad Hassan Eftekhari, professor, Study Director, Shiraz University of Medical Sciences

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