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InflammationPhase 3NCT01147354

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

A Phase 3 study testing selenium yeast in people with Inflammation and Malnutrition, run by Zahra Sohrabi at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
What is being tested?
selenium yeast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteIran
Study dates
Apr 2009to Sep 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Shiraz University of Medical Sciences

    Shiraz, Fars

Other trials in Iran

About this study

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.

Being tested
selenium yeast, placebo capsules
Keywords
Hemodialysis, oxidative stress, selenium, inflammation
Medical subject headings
Inflammation, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • selenium yeastDietary supplement

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

  • placebo capsulesOther

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

Study groups in NCT01147354
Study groupRoleWhat they receive
experimental groupExperimentalThe patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
Receives: Dietary Supplement: selenium yeast
control groupPlacebo comparatorThe patients in this arm took one placebo capsule daily for 12 weeks.
Receives: Other: placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Global Assessment

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

    Measured: 12-weeks

Secondary outcomes (14)

  1. serum albumin

    Measured: 12-weeks

  2. hemoglobin

    Measured: 12-weeks

  3. serum malondialdehyde

    Measured: 12-weeks

  4. serum parathyroid hormone

    Measured: 12-weeks

  5. serum interleukin-6

    Measured: 12-weeks

  6. serum phosphorus

    Measured: 12-weeks

  7. serum high sensitive c-reactive protein

    Measured: 12-weeks

  8. serum calcium

    Measured: 12-weeks

  9. serum lipoproteins

    Measured: 12-weeks

  10. serum ferritin

    Measured: 12-weeks

  11. serum homocysteine

    Measured: 12-weeks

  12. total iron binding capacity (TIBC)

    Measured: 12-weeks

  13. body mass index (BMI)

    Measured: 12-weeks

  14. malnutrition-inflammation score (MIS)

    Measured: 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01147354
Sponsor's protocol ID
88-4747
Status last verified
Jan 2012
First submitted
17 Jun 2010
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37916745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing selenium yeast in people with Inflammation and Malnutrition, run by Zahra Sohrabi at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Global Assessment (time frame: 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01147354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.

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