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Completed

NCT Number: NCT01150786

Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients

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.

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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

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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 give their informed consent to participate in this trial.The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients are randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and followed for 12 weeks.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 cannulae just before the beginning of the HD session. The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C. Serum levels of adiponectin,high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium, phosphate, albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels (g/dL) were measured in all patients at the baseline and at the end of treatment phase of study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

selenium supplement

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Subjective global Assessment(SGA)score

    Time frame: 12 Weeks

    change in nutritional status according to SGA from baseline to the end of intervention

Secondary outcomes

  1. Serum HSCRP

    Time frame: 12Weeks

  2. serum ferritin

    Time frame: 12Weeks

  3. transferrin

    Time frame: 12 weeks

  4. Serum adiponectin

    Time frame: 12Weeks

  5. Homocystein

    Time frame: 12 Weeks

  6. Serum albumin

    Time frame: 12Weeks

  7. Malnutrition inflammation score(MIS)

    Time frame: 12 Weeks

  8. Quality of life

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

maryam ekramzadeh

Other

Collaborators

  • Shiraz University of Medical Sciences

Registry information

Official study title

Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 25, 2010
Registry last updated
Feb 14, 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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