Protocol summary

Summary
The aim of this study is to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients. 92 hemodialysis patients will be selected for the study. 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. Weight and height of the patients will be recorded for BMI (body mass index) calculation. Informed consent will be signed by all of them for participating in the study. Then, all of the patients will be divided into 4 groups: 1-consumption of 230 milliliters of whey drink three times a week, 2-consumption of 230 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 will be followed for 2 months. At the beginning and the end of the 2-month intervention period, 10 milliliters of blood will be taken from all of the patients and nutritional status of the patients will be assessed as the primary outcome. Serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and lipoproteins will be measured. SGA, MIS and SF-12 questionnaires will be filled for all of the patients at the beginning and the end of the study.

General information

Acronym
EVEWD
IRCT registration information
IRCT registration number: IRCT201312132480N4
Registration date: 2013-12-28, 1392/10/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-28, 1392/10/07
Registrant information
Name
Mohammad Hassan Eftekhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
eftekharim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients
Public title
Evaluating the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
91-6424

2

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91-6424

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
Malnutrition
Timepoint
2 months
Method of measurement
SGA assessment

2

Description
Malnutrition
Timepoint
2 months
Method of measurement
SGA assessment

Secondary outcomes

1

Description
Serum levels of malondialdehyde
Timepoint
2 months
Method of measurement
TBA method (biochemical)

2

Description
Serum levels of c-reactive protein
Timepoint
2 months
Method of measurement
ELISA kit

3

Description
serum transferrin
Timepoint
2-months
Method of measurement
autoanalyzer

4

Description
Serum levels of albumin
Timepoint
2-months
Method of measurement
autoanalyzer

5

Description
serum lipoproteins
Timepoint
2-months
Method of measurement
autoanalyzer

6

Description
Subjective Global Assessment
Timepoint
2-months
Method of measurement
Questionnaire

7

Description
quality of life
Timepoint
2-months
Method of measurement
SF-12 questionnaire

8

Description
MIS
Timepoint
2-months
Method of measurement
Questionnaire

9

Description
weight
Timepoint
2-months
Method of measurement
scale

Intervention groups

1

Description
Consumption of 230 milliliters of whey drink three times a week
Category
Treatment - Other

2

Description
Consumption of 230 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week
Category
Treatment - Other

3

Description
Control group: no intervention
Category
N/A

4

Description
Consumption of 400 milligrams of vitamin E three times a week
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faghihi and Namazi hospitals, Dialysis centers of Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz

2

Recruitment center
Name of recruitment center
Shahid Faghihi and Namazi hospitals, Dialysis centers of Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Postforosh
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Postforosh
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Zahra Sohrabi
Position
PhD Candidate
Other areas of specialty/work
Street address
Mehr Building, Lane 4/A, Iman Jonobi Avenue, Shiraz, Iran
City
Shiraz
Postal code
00989177113086
Phone
+98 917 711 3086
Fax
Email
Zahra_2043@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hassan Eftekhari
Position
Assiciate Professor
Other areas of specialty/work
Street address
Razi Avenue, School of Nutrition and Food Science, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 917 708 8717
Fax
Email
h_eftekhari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
PhD candidate
Other areas of specialty/work
Street address
Mehr Building, Lane 4/A, Iman Jonobi Avenue, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 917 711 3086
Fax
Email
Zahra_2043@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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