End Stage Renal FailureNCT01101217
Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients
A study testing Zinc Supplement in people with End Stage Renal Failure, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Failure
- What is being tested?
- Zinc Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Feb 2009to Sep 2009
- Phase
- Interventional
- 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
- hemodialysis for 3 months
- older than 18 years old
- serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female
Who cannot join
- acute renal failre
- malabsorption
- history of steroid or cytotoxic consumption
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.
Read the detailed description
hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.
- Conditions
- End Stage Renal Failure
- Being tested
- Zinc Supplement, placebo
- Keywords
- hemocystein zinc renal failure
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SupplementDrug
in 50 patients zinc sulfate 220 mg per day orally for 6 weeks
placeboDrug
placebo daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo for 6 weeks Receives: Drug: placebo |
| zinc | Active comparator | zinc sulfate 220 mg per day orally for 6 weeks Receives: Drug: Zinc Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreased hemocystein level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101217
- Sponsor's protocol ID
- 4542
- Status last verified
- Jan 2009
- First submitted
- 8 Apr 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01101217
- Acronym / sponsor ID
- 4542
- Conditions
- End Stage Renal Failure
- Keywords
- hemocystein zinc renal failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.
Detailed description
hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo for 6 weeks |
| zinc | Active comparator | Drug: Zinc Supplementzinc sulfate 220 mg per day orally for 6 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hemodialysis for 3 months
- older than 18 years old
- serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female
Key exclusion criteria (3 listed)
- acute renal failre
- malabsorption
- history of steroid or cytotoxic consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Supplementin 50 patients zinc sulfate 220 mg per day orally for 6 weeks | Drug | zinc |
| placeboplacebo daily for 6 weeks | Drug | placebo |
Primary outcome
decreased hemocystein level
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Supplement in people with End Stage Renal Failure, run by Shiraz University of Medical Sciences 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 3 inclusion and 3 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 9 Apr 2010. 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.
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?
decreased hemocystein level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2010.