Dietary Selenium DeficiencyNCT01547377
Zinc and Selenium Supplementation in Atherosclerosis
A study testing zinc and selenium supplementation in people with Dietary Selenium Deficiency and Dietary Zinc Deficiency, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The aim of this randomized double-blind study was to evaluate the effect of oral zinc and selenium supplementation on oxidative stress and inflammation biomarkers as well as the status of zinc and selenium in patients with atherosclerosis and angina stable treated with rosuvastatin. Read more about this study
- Who is it for?
- Ages 41 to 80 years
- Conditions the study is for
- Dietary Selenium Deficiency, Dietary Zinc Deficiency
- What is being tested?
- zinc and selenium supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Nov 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 41 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study included adult and elderly patients, with coronary atherosclerosis and stable angina diagnosed by angiography showing ≥ 70% stenosis of the vessel lumen in at least one segment of a major epicardial artery or ≥ 50% stenosis of the diameter of the left main coronary artery, stable angina
Who cannot join
- Cardiac complications or other serious diseases such as:
- thyroid,
- hematologic,
- congenital,
- autoimmune liver disease,
- kidney failure,
Show all 16Show fewer
- cancer,
- associated infections,
- osteoporosis,
- post-operative,
- use of:
- antacids,
- antibiotics and
- vitamin-mineral supplements,
- alcohol and
- current smoking.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Onofre Lopes University Hospital
Natal, Rio Grande do Norte, 59.012.300
About this study
Official title: Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins
The aim of this randomized double-blind study was to evaluate the effect of oral zinc and selenium supplementation on oxidative stress and inflammation biomarkers as well as the status of zinc and selenium in patients with atherosclerosis and angina stable treated with rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and anti-inflammatory as well as the status of minerals?
Read the detailed description
The study included 47 men and 29 women, average age around 60 years, with coronary atherosclerosis diagnosed by angiography. Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients.
- Being tested
- zinc and selenium supplementation, rosuvastatin + placebo
- Keywords
- atherosclerosis, zinc and selenium status, rosuvastatin, oxidative stress biomarkers, inflammation biomarkers
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc and selenium supplementationDietary supplement
Also called Zinc and selenium supplementation + rosuvastatin
Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
rosuvastatin + placeboOther
Also called placebo group
Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
| Study group | Role | What they receive |
|---|---|---|
| zinc and selenium supplementation | Experimental | Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months Receives: Dietary Supplement: zinc and selenium supplementation |
| rosuvastatin + placebo | Placebo comparator | Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation Receives: Other: rosuvastatin + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in zinc and selenium status at 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on plasma zinc and selenium and on erythrocyte zinc and selenium.
Measured: Baseline and 4 months
Secondary outcomes (3)
Change from baseline in lipid profile at 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on total cholesterol, LDL, non-HDL cholesterol and, triglycerides.
Measured: Baseline and 4 months
Change from baseline in zinc and selenium status at 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on LDL (-), anti-LDL (-), immune complexes concentrations, SOD and GPx activities.
Measured: Baseline and 4 months
Change from baseline in inflammation biomarkers status at 4 months
We evaluated the effect of oral zinc and selenium supplementation, concomitant with rosuvastatin treatment, on hs-CRP and IL-6 levels.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2008
- Primary completionApr 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary Selenium DeficiencyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Karine C M Sena-Evangelista, Universidade Federal do Rio Grande do Norte
- Investigators
- Dulcineia SP Abdalla, PhD, Study director, University of Sao PauloLucia FC Pedrosa, PhD, Study director, University of Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547377
- Sponsor's protocol ID
- PROJ-981-199697778
- Status last verified
- Mar 2012
- First submitted
- 22 Feb 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sena-Evangelista KC, Pedrosa LF, Paiva MS, Dias PC, Ferreira DQ, Cozzolino SM, Faulin TE, Abdalla DS. The hypolipidemic and pleiotropic effects of rosuvastatin are not enhanced by its association with zinc and selenium supplementation in coronary artery disease patients: a double blind randomized controlled study. PLoS One. 2015 Mar 18;10(3):e0119830. doi: 10.1371/journal.pone.0119830. eCollection 2015.
PubMed 25785441
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins
- ClinicalTrials.gov ID
- NCT01547377
- Acronym / sponsor ID
- PROJ-981-199697778
- Keywords
- atherosclerosis, zinc and selenium status, rosuvastatin, oxidative stress biomarkers, inflammation biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jan 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Mar 2012 (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 aim of this randomized double-blind study was to evaluate the effect of oral zinc and selenium supplementation on oxidative stress and inflammation biomarkers as well as the status of zinc and selenium in patients with atherosclerosis and angina stable treated with rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and anti-inflammatory as well as the status of minerals?
Detailed description
The study included 47 men and 29 women, average age around 60 years, with coronary atherosclerosis diagnosed by angiography. Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc and selenium supplementation | Experimental | Dietary Supplement: zinc and selenium supplementationPatients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months |
| rosuvastatin + placebo | Placebo comparator | Other: rosuvastatin + placeboPatients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation |
Who may qualify
- Ages
- 41 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study included adult and elderly patients, with coronary atherosclerosis and stable angina diagnosed by angiography showing ≥ 70% stenosis of the vessel lumen in at least one segment of a major epicardial artery or ≥ 50% stenosis of the diameter of the left main coronary artery, stable angina
Key exclusion criteria (16 listed)
- Cardiac complications or other serious diseases such as:
- autoimmune liver disease,
- kidney failure,
- cancer,
- associated infections,
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 and selenium supplementationAlso: Zinc and selenium supplementation + rosuvastatinData from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients | Dietary supplement | zinc and selenium supplementation |
| rosuvastatin + placeboAlso: placebo groupData from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients | Other | rosuvastatin + placebo |
Primary outcome
Change from baseline in zinc and selenium status at 4 months
Time frame: Baseline and 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on plasma zinc and selenium and on erythrocyte zinc and selenium.
3 secondary outcomes
Change from baseline in lipid profile at 4 months
Time frame: Baseline and 4 months
Change from baseline in zinc and selenium status at 4 months
Time frame: Baseline and 4 months
Change from baseline in inflammation biomarkers status at 4 months
Time frame: Baseline and 4 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 7 Mar 2012.
- Derived from this study: PubMed 25785441Sena-Evangelista KC, Pedrosa LF, Paiva MS, Dias PC, Ferreira DQ, Cozzolino SM, Faulin TE, Abdalla DS. The hypolipidemic and pleiotropic effects of rosuvastatin are not enhanced by its association with zinc and selenium supplementation in coronary artery disease patients: a double blind randomized controlled study. PLoS One. 2015 Mar 18;10(3):e0119830. doi: 10.1371/journal.pone.0119830. eCollection 2015.
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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.
Dulcineia SP Abdalla, PhD study director
University of Sao Paulo
Lucia FC Pedrosa, PhD study director
University of Rio Grande do Norte
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 and selenium supplementation in people with Dietary Selenium Deficiency and Dietary Zinc Deficiency, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 16 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 7 Mar 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 Brazil. 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?
Change from baseline in zinc and selenium status at 4 months (time frame: Baseline and 4 months). 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 NCT01547377, 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 7 Mar 2012.