The aim of this study was to assess the effects of selenium supplement on inflammatory, oxidative and nutritional markers in hemodialysis patients. The study was done on 80 patients undergoing hemodialysis. We included the ones who were being dialyzed at least twice a week and had undergone dialysis at least for 3 months. Subjects were excluded if they were prescribed any multivitamins or immunosuppressive drugs or if they had been hospitalized in the previous month; we also excluded the ones who were pregnant or had active infections. After taking written consent, blood samples were taken to measure their lipoprotein, malondialdehyde, interleukin-6, c-reactive protein, calcium, phosphorus and parathyroid hormone, then patients in control group received a placebo capsule a day (was made of starch) during the 3-month of trial period and patients in the experimental group received 200 microgram selenium in the form of selenium yeast (a capsule a day) for three months. Blood samples were taken again after 3 months and biochemical measurements were done. Every patient filled the SF-36 questionnaire and 3-day dietary recall and their weights were recorded at the beginning and after 3 months. Assessing SGA and appetite status were also done for every patient by interviewing at the beginning and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812083446N1
Registration date:2009-04-04, 1388/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-04-04, 1388/01/15
Registrant information
Name
Zahra Sohrabi
Name of organization / entity
Nutrition department, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1630 0784
Email address
sohrabi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences,transplantation research center
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2009-07-06, 1388/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of selenium supplement on inflammatory, oxidative and nutritional markers in hemodialysis patients
Public title
Determining the effect of selenium supplement on inflammatory, oxidative and nutritional markers in hemodialysis patients in shiraz medical university hemodialysis centers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being on dialysis at least 2-3 sessions per week for 3 months, age range of 17-85 years. Exclusion criteria: being admitted in hospital during last month, having active infection, using multivitamins or immunosupressive drugs, being pregnant.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
2009-09-29, 1388/07/07
Ethics committee reference number
88-4747
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
malondialdehyde (oxidative stress)
Timepoint
2 times with 3 months interval
Method of measurement
spectrophotometery
Secondary outcomes
1
Description
subjective global assesment
Timepoint
2 times with 3 months interval
Method of measurement
questinnaire
2
Description
serum albumin
Timepoint
2 times with 3 months interval
Method of measurement
ELISA kit
3
Description
Interleukin-6
Timepoint
2 times with 3 months interval
Method of measurement
ELISA kit
4
Description
c-reactive proteins
Timepoint
2 times with 3 months interval
Method of measurement
ELISA kit
5
Description
food intake
Timepoint
2 times with 3 months interval
Method of measurement
questinnaire
Intervention groups
1
Description
Treatment group:200 micrograms of selenium supplement for 3 months
Category
Treatment - Drugs
2
Description
Control group: an starch capsule for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital and Namazi hospital
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.Mohammad Hassan Dabbaghmanesh
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
100
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 Shrabi
Position
Ph.D student in nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 917 711 3086
Fax
Email
zahra_2043@yahoo.com , sohrabi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Moosa Salehi
Position
Associate professor in nutrition
Other areas of specialty/work
Street address
Nutrition department, Namazi hospital, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1002
Fax
Email
moosasalehi@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
Ph.D student in nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1630 0784
Fax
Email
zahra_2043@yahoo.com , sohrabi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)