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Oxidative StressPhase 3NCT01150786

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

A Phase 3 study testing Selenium Supplement in people with Oxidative Stress and Inflammation, run by maryam ekramzadeh at 2 sites 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 determine the effect of selenium supplementation as an antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine level. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Oxidative Stress, Inflammation, Malnutrition
What is being tested?
Selenium Supplement
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
2 sitesIran
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 dialysed three times a week for at least 3 months or more

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Iran2 sites

  • Shiraz University of Medical Sciences , nutrition department

    Shiraz, Fars

  • Shiraz University of Medical Sciences

    Shiraz, Fars

Other trials in Iran

About this study

Official title: Effect of Selenium Supplementation on Serum Adiponectin and Homocystein

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.

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 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.

Being tested
Selenium Supplement, placebo
Keywords
inflammation, oxidative stress, selenium, hemodialysis
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 SupplementDietary supplement

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

  • placeboOther

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

Study groups in NCT01150786
Study groupRoleWhat they receive
seleniumExperimentalThe patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
Receives: Dietary Supplement: Selenium Supplement
placebo capsulePlacebo comparatorThe patients in this arm took one placebo capsule daily for 12 weeks.
Receives: Other: placebo

What is being measured

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

  1. Subjective global Assessment(SGA)score

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

    Measured: 12 Weeks

Secondary outcomes (8)

  1. Serum HSCRP

    Measured: 12Weeks

  2. serum ferritin

    Measured: 12Weeks

  3. transferrin

    Measured: 12 weeks

  4. Serum adiponectin

    Measured: 12Weeks

  5. Homocystein

    Measured: 12 Weeks

  6. Serum albumin

    Measured: 12Weeks

  7. Malnutrition inflammation score(MIS)

    Measured: 12 Weeks

  8. Quality of life

    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 posted25 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
NCT01150786
Sponsor's protocol ID
884746
Status last verified
Feb 2012
First submitted
22 Jun 2010
Last updated
14 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selenium Supplement in people with Oxidative Stress and Inflammation, run by maryam ekramzadeh at 2 sites 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 14 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 2 sites 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(SGA)score (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 NCT01150786.

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 14 Feb 2012.

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