Zinc and Selenium Supplementation in Atherosclerosis

Condition(s) targeted: Dietary Selenium Deficiency; Dietary Zinc Deficiency

Intervention: zinc and selenium supplementation (Dietary Supplement); rosuvastatin + placebo (Other)

Phase: N/A

Status: Completed

Sponsored by: Universidade Federal do Rio Grande do Norte

Official(s) and/or principal investigator(s):
Dulcineia SP Abdalla, PhD, Study Director, Affiliation: University of São Paulo
Lucia FC Pedrosa, PhD, Study Director, Affiliation: University of Rio Grande do Norte

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?

Official title: Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in zinc and selenium status at 4 months

Secondary outcome:

Change from baseline in lipid profile at 4 months

Change from baseline in zinc and selenium status at 4 months

Change from baseline in inflammation biomarkers status at 4 months

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.

Minimum age: 41 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Onofre Lopes University Hospital, Natal, Rio Grande do Norte 59.012.300, Brazil

Starting date: January 2008
Last updated: March 2, 2012