Determining the effect of selenium supplement on serum adiponectin and homocystein levels and malnutrition-inflammation complex syndrome (MICS) in hemodialysis patients
In order to evaluate the effect of selenium supplementation on serum adiponectin and homocystein concentrations and markers of malnutrition-inflamation complex syndrome (MICS) in hemodialysis patients, a randomized double blind clinical trial was done. Eighty hemodialysis patients with the age range of 17-85 years who were on dialysis at least 2 times per week without any infection or hospitalization were divided into two groups of control and experimental and they took placebo (containing yeast) and selenium (200 microgram) for 3 months respectively. Before and after the intervention, in all patients, serum concentrations of adiponectin, homocystein, ferritin, transferin, albumin and CRP were measured by ELISA kits and each patient had 3-day food intake and SF-36 quality life questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812043408N1
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
Maryam Ekramzadeh
Name of organization / entity
Shiraz University of Medical Sciences, Nutrition Department
Country
Iran (Islamic Republic of)
Phone
+98 917 317 3891
Email address
ekramzadeh@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 serum adiponectin and homocystein levels and malnutrition-inflammation complex syndrome (MICS) in hemodialysis patients
Public title
Effect of selenium on malnutrition- inflamation complex syndrome (MICS) in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: hemodialysis patients who are on dialysis at least two times per week and in the age range of 17-85 years. Exclusion Criteria: having infection, hospitalization, taking multivitamins, antibiotics or immunosuppressents, being pregnant.
Age
From 18 years old to 80 years old
Gender
Both
Phase
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT01150786
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
71345-1978
Approval date
2009-09-27, 1388/07/05
Ethics committee reference number
88-4746
Health conditions studied
1
Description of health condition studied
End stage renal disease , hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
adiponectin
Timepoint
2 times with 3 months interval
Method of measurement
ELISA kit
2
Description
CRP
Timepoint
2 times with 3 months interval
Method of measurement
ELISA kit
3
Description
homocystein
Timepoint
2 times with 3 months interval
Method of measurement
ELISA kit
Secondary outcomes
1
Description
ferritin
Timepoint
2 times wiyh 3 months interval
Method of measurement
ELISA kit
2
Description
albumin
Timepoint
2 times with 3 months interval
Method of measurement
autoanalyzer
3
Description
transferrin
Timepoint
2 times with 3 months interval
Method of measurement
manual method
4
Description
subjective global assesment
Timepoint
2 times with 3 months interval
Method of measurement
questionnaire
5
Description
food intake
Timepoint
2 times with 3 months interval
Method of measurement
questionnaire
6
Description
quality of life
Timepoint
2 times with 3 months interval
Method of measurement
questionnaire
Intervention groups
1
Description
treatment group: 200 microgram of selenium supplement per day for 3 months
Category
Treatment - Drugs
2
Description
control group: an starch capsule per day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi and Nemazi hospitals of Shiraz
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
Zand street
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
Maryam Ekramzade
Position
Master of sciences in nutrition
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1624 4621
Fax
Email
m_ekramzade@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. Moosa Salehi
Position
Associate professor in nutrition
Other areas of specialty/work
Street address
Nutrition department, School of health and nutrition, 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
Maryam Ekramzade
Position
Master of sciences
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1624 4621
Fax
Email
m_ekramzade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)