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Completed

NCT Number: NCT01147354

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

selenium yeast

Dietary Supplement

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

Placebo Capsules

Other

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

Primary outcomes

  1. Subjective Global Assessment

    Time frame: 12-weeks

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

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

Sponsors and collaborators

Lead sponsor

Zahra Sohrabi

Other

Collaborators

  • Shiraz University of Medical Sciences

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 22, 2010
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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