NCT01147354

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

June 17, 2010

Last Update Submit

January 31, 2012

Conditions

InflammationMalnutritionComplication of Hemodialysis

Keywords

Hemodialysisoxidative stressseleniuminflammation

Outcome Measures

Primary Outcomes (1)

  • Subjective Global Assessment

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

    12-weeks

Secondary Outcomes (14)

  • serum albumin

    12-weeks

  • hemoglobin

    12-weeks

  • serum malondialdehyde

    12-weeks

  • serum parathyroid hormone

    12-weeks

  • serum interleukin-6

    12-weeks

  • +9 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

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

Dietary Supplement: selenium yeast

control group

PLACEBO COMPARATOR

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

Other: placebo capsules

Interventions

selenium yeastDIETARY_SUPPLEMENT

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

experimental group
placebo capsulesOTHER

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

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Related Publications (1)

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

MeSH Terms

Conditions

InflammationMalnutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Zahra Sohrabi, Ph.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mohammad mahdi Sagheb, M.D

    Shiraz University of Medical Sciences

    STUDY CHAIR

  • Moosa Salehi, Ph.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Maryam Ekramzadeh, Ph.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mohammad Kazem Fallahzadeh, M.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Maryam Ayatollahi, Ph.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Bita Geramizadeh, M.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Jafar Hassanzadeh, Ph.D

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

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 17, 2010

First Posted

June 22, 2010

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

IR(1)