Zinc and Selenium Supplementation in Atherosclerosis

Universidade Federal do Rio Grande do Norte

Status: Completed

Conditions: Dietary Zinc Deficiency; Dietary Selenium Deficiency

Treatments: Dietary Supplement: zinc and selenium supplementation; Other: rosuvastatin + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01547377

PROJ-981-199697778

Details and patient eligibility

About

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?

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 41 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

zinc and selenium supplementation

Experimental group

Description:

Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months

Treatment:

Dietary Supplement: zinc and selenium supplementation

rosuvastatin + placebo

Placebo Comparator group

Description:

Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation

Treatment:

Other: rosuvastatin + placebo