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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
whey drink,
whey drink fortified with vitaminE
vitamin E
Sponsored by
Mohammad Hassan Eftekhari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring whey protein, malnutrition, oxidative stress, hemodialysis

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

  • hospitalization in the last month;
  • active infection;
  • using immunosuppressant drugs or multi-vitamins;
  • pregnancy, consuming whey or soy products

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    whey drink

    whey drink fortified with vitaminE

    vitaminE

    D- control

    Arm Description

    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,

    Outcomes

    Primary Outcome Measures

    malnutrition (based on SGA assessment)
    Malnutrition inflammation score

    Secondary Outcome Measures

    serum interleukin-6
    serum C-reactive protein
    serum albumin
    serum HDL-c
    serum total cholesterol
    serum triglyceride
    serum transferrin
    serum malondialdehyde
    BUN (blood urea nitrogen)
    serum creatinine
    serum calcium
    serum phosphate
    quality of life
    weight
    height
    Body mass index

    Full Information

    First Posted
    June 10, 2014
    Last Updated
    January 8, 2015
    Sponsor
    Mohammad Hassan Eftekhari
    Collaborators
    Shiraz University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02163070
    Brief Title
    Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients
    Acronym
    EVEWD
    Official Title
    Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohammad Hassan Eftekhari
    Collaborators
    Shiraz University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease
    Keywords
    whey protein, malnutrition, oxidative stress, hemodialysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    whey drink
    Arm Type
    Experimental
    Arm Description
    consumption of 220 milliliters of whey drink three times a week,
    Arm Title
    whey drink fortified with vitaminE
    Arm Type
    Experimental
    Arm Description
    consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
    Arm Title
    vitaminE
    Arm Type
    Experimental
    Arm Description
    consumption of 400 milligrams of vitamin E three times a week,
    Arm Title
    D- control
    Arm Type
    No Intervention
    Arm Description
    control group: no intervention,
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    whey drink,
    Intervention Description
    consumption of 220 milliliters of whey drink three times a week,
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    whey drink fortified with vitaminE
    Intervention Description
    consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    vitamin E
    Intervention Description
    consumption of 400 milligrams of vitamin E three times a week,
    Primary Outcome Measure Information:
    Title
    malnutrition (based on SGA assessment)
    Time Frame
    2 months (8 weeks)
    Title
    Malnutrition inflammation score
    Time Frame
    2 months (8 weeks)
    Secondary Outcome Measure Information:
    Title
    serum interleukin-6
    Time Frame
    2 months (8 weeks)
    Title
    serum C-reactive protein
    Time Frame
    2 months (8 weeks)
    Title
    serum albumin
    Time Frame
    2 months (8 weeks)
    Title
    serum HDL-c
    Time Frame
    2 months (8 weeks)
    Title
    serum total cholesterol
    Time Frame
    2 months (8 weeks)
    Title
    serum triglyceride
    Time Frame
    2 months (8 weeks)
    Title
    serum transferrin
    Time Frame
    2 months (8 weeks)
    Title
    serum malondialdehyde
    Time Frame
    2 months (8 weeks)
    Title
    BUN (blood urea nitrogen)
    Time Frame
    2 months (8 weeks)
    Title
    serum creatinine
    Time Frame
    2 months (8 weeks)
    Title
    serum calcium
    Time Frame
    2 months (8 weeks)
    Title
    serum phosphate
    Time Frame
    2 months (8 weeks)
    Title
    quality of life
    Time Frame
    2 months (8 weeks)
    Title
    weight
    Time Frame
    2 months (8 weeks)
    Title
    height
    Time Frame
    2 months (8 week)
    Title
    Body mass index
    Time Frame
    2 months (8 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammad Hassan Eftekhari, professor
    Organizational Affiliation
    Shiraz University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32390133
    Citation
    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.
    Results Reference
    derived

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

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