Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients
EVEWD
1 other identifier
interventional
92
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2013
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedJanuary 9, 2015
January 1, 2015
6 months
June 10, 2014
January 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
malnutrition (based on SGA assessment)
2 months (8 weeks)
Malnutrition inflammation score
2 months (8 weeks)
Secondary Outcomes (16)
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)
- +11 more secondary outcomes
Study Arms (4)
whey drink
EXPERIMENTALconsumption of 220 milliliters of whey drink three times a week,
whey drink fortified with vitaminE
EXPERIMENTALconsumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
vitaminE
EXPERIMENTALconsumption of 400 milligrams of vitamin E three times a week,
D- control
NO INTERVENTIONcontrol group: no intervention,
Interventions
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,
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- hospitalization in the last month;
- active infection;
- using immunosuppressant drugs or multi-vitamins;
- pregnancy, consuming whey or soy products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mohammad Hassan Eftekharilead
- Shiraz University of Medical Sciencescollaborator
Related Publications (1)
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.
PMID: 32390133DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammad Hassan Eftekhari, professor
Shiraz University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor. PhD
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 13, 2014
Study Start
September 1, 2013
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
January 9, 2015
Record last verified: 2015-01