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CompletedNCT01147354Updated Feb 2, 2012

Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients

A Phase 3 interventional study of selenium yeast and placebo capsules in Inflammation, Malnutrition and Complication of Hemodialysis, sponsored by Zahra Sohrabi. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-02.

Sponsored by Zahra Sohrabi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.

Read the detailed description

After screening all of 280 patients under regular HD in Faghihi Hospital Hemodialysis Center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and gave their informed consent to participate in this trial. Subjects were excluded if they were prescribed any multivitamins or immunosuppressive drugs or taking antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study or if they had been hospitalized in the previous month, we also excluded the ones who were pregnant or had active infections. The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients were randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and were followed for 12 weeks.In order to determine the nutritional statuses of all patients, at the baseline, the questions of SGA and MIS questionnaire were read to the patients and completed in person by the main investigator. The questions of SGA and MIS were also asked by the same person at the end of treatment phase.Before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient.The blood was taken from the patient's arm used for hemodialysis cannula just before the beginning of the hemodialysis procedure. The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C. Serum levels of malondialdehyde (MDA), interleukin-6 (IL-6), high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium , phosphate, parathyroid hormone (PTH), albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels were measured in all patients at the baseline and at the end of treatment phase of study.The aim of this study was to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.

02

Conditions studied

  • Inflammation
  • Malnutrition
  • Complication of Hemodialysis

Keywords

  • Hemodialysis
  • oxidative stress
  • selenium
  • inflammation
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

This is the only study on the registry with Zahra Sohrabi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who were dialyzed three times a week at least for 3 months or more

Exclusion criteria

Exclusion Criteria:

  • Patients who took any multivitamins or immunosuppressive drugs within 2 months prior to enrollment in the study
  • Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid,omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study
  • Patients who were Hospitalized in the previous month
  • Patients who had active infections
  • Being pregnant
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    experimental group

    The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.

    Dietary Supplement: selenium yeast

  • Placebo comparator
    control group

    The patients in this arm took one placebo capsule daily for 12 weeks.

    Other: placebo capsules

Interventions

  • Dietary supplementselenium yeast

    The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.

  • Otherplacebo capsules

    The patients in this arm took one placebo capsule daily for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Subjective Global Assessment

    changes in nutritional status according to SGA from baseline to end of treatment

    Time frame: 12-weeks

Secondary outcomes

  1. serum albumin

    Time frame: 12-weeks

  2. hemoglobin

    Time frame: 12-weeks

  3. serum malondialdehyde

    Time frame: 12-weeks

  4. serum parathyroid hormone

    Time frame: 12-weeks

  5. serum interleukin-6

    Time frame: 12-weeks

  6. serum phosphorus

    Time frame: 12-weeks

  7. serum high sensitive c-reactive protein

    Time frame: 12-weeks

  8. serum calcium

    Time frame: 12-weeks

  9. serum lipoproteins

    Time frame: 12-weeks

  10. serum ferritin

    Time frame: 12-weeks

  11. serum homocysteine

    Time frame: 12-weeks

  12. total iron binding capacity (TIBC)

    Time frame: 12-weeks

  13. body mass index (BMI)

    Time frame: 12-weeks

  14. malnutrition-inflammation score (MIS)

    Time frame: 12-weeks

07

Study locations

1 site
  • Shiraz University of Medical Sciences
    Shiraz, Fars, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01147354
Lead sponsor
Zahra Sohrabi
Collaborators
Shiraz University of Medical Sciences
Responsible party
Zahra Sohrabi (Ph.D, Shiraz University of Medical Sciences) — Sponsor-investigator
First posted
Jun 22, 2010
Start date
Apr 2009
Primary completion
Jul 2009
Completion
Sep 2009
Last update
Feb 2, 2012

Study contacts

Zahra Sohrabi, Ph.D
principal investigator · Shiraz University of Medical Sciences
Mohammad mahdi Sagheb, M.D
study chair · Shiraz University of Medical Sciences
Moosa Salehi, Ph.D
principal investigator · Shiraz University of Medical Sciences
Maryam Ekramzadeh, Ph.D
principal investigator · Shiraz University of Medical Sciences
Mohammad Kazem Fallahzadeh, M.D
principal investigator · Shiraz University of Medical Sciences
Maryam Ayatollahi, Ph.D
principal investigator · Shiraz University of Medical Sciences
Bita Geramizadeh, M.D
principal investigator · Shiraz University of Medical Sciences
Jafar Hassanzadeh, Ph.D
principal investigator · Shiraz University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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