Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients
Effect of Selenium Supplementation on Serum Adiponectin and Homocystein
1 other identifier
interventional
80
1 country
2
Brief Summary
The aim of this study is to determine the effect of selenium supplementation as an antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Shorter than P25 for phase_3
2 active sites
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
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 25, 2010
CompletedFebruary 14, 2012
February 1, 2012
3 months
June 22, 2010
February 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective global Assessment(SGA)score
change in nutritional status according to SGA from baseline to the end of intervention
12 Weeks
Secondary Outcomes (8)
Serum HSCRP
12Weeks
serum ferritin
12Weeks
transferrin
12 weeks
Serum adiponectin
12Weeks
Homocystein
12 Weeks
- +3 more secondary outcomes
Study Arms (2)
selenium
EXPERIMENTALThe patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
placebo capsule
PLACEBO COMPARATORThe patients in this arm took one placebo capsule daily for 12 weeks.
Interventions
The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- Patients who were dialysed three times a week for at least 3 months or more
You may not qualify if:
- Patients who took multivitamins or immunosuppressive medications
- Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations
- Patients who had active infection
- Patients who were hospitalized in the previous month.
- Being Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- maryam ekramzadehlead
- Shiraz University of Medical Sciencescollaborator
Study Sites (2)
Shiraz University of Medical Sciences , nutrition department
Shiraz, Fars, Iran
Shiraz University of Medical Sciences
Shiraz, Fars, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
maryam ekramzade, Ph.D
Shiraz University of Medical Sciences
- STUDY DIRECTOR
moosa salehi, Ph.D
Shiraz University of Medical Sciences
- STUDY CHAIR
maryam ayatollahi, Ph.D
Shiraz University of Medical Sciences
- STUDY CHAIR
Mohammad mahdi Sagheb, M.D
Shiraz University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ph.D
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 25, 2010
Study Start
April 1, 2009
Primary Completion
July 1, 2009
Study Completion
September 1, 2009
Last Updated
February 14, 2012
Record last verified: 2012-02