Clinical trial NCT01547377: Zinc and Selenium Supplementation in Atherosclerosis
Official title: Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Selenium Deficiency
Dietary Zinc Deficiency
Keywords: atherosclerosis
zinc and selenium status
rosuvastatin
oxidative stress biomarkers
inflammation biomarkers
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2012-03-07
Enrollment: 76
Sex: ALL
Minimum age (years): 41
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Cardiac complications or other serious diseases such as:

  * thyroid,
  * hematologic,
  * congenital,
* autoimmune liver disease,
* kidney failure,
* cancer,
* associated infections,
* osteoporosis,
* post-operative,
* use of:

  * antacids,
  * antibiotics and
  * vitamin-mineral supplements,
* alcohol and
* current smoking.

Primary outcomes:
measure: Change from baseline in zinc and selenium status at 4 months
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change from baseline in lipid profile at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline in zinc and selenium status at 4 months
timeFrame: Baseline and 4 months
measure: Change from baseline in inflammation biomarkers status at 4 months
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Onofre Lopes University Hospital
state: Rio Grande do Norte
Study officials:
affiliation: University of Sao Paulo
name: Dulcineia SP Abdalla, PhD
role: STUDY_DIRECTOR
affiliation: University of Rio Grande do Norte
name: Lucia FC Pedrosa, PhD
role: STUDY_DIRECTOR
References:
citation: 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.