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
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring whey protein, malnutrition, oxidative stress, hemodialysis
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
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
NCT ID
NCT02163070
First Posted
June 10, 2014
Last Updated
January 8, 2015
Sponsor
Mohammad Hassan Eftekhari
Collaborators
Shiraz University of Medical Sciences
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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