Zinc and Selenium Supplementation in Atherosclerosis

NCT01547377 | Completed

• 1 other identifier: PROJ-981-199697778
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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?

Conditions

Dietary Selenium Deficiency; Dietary Zinc Deficiency

Keywords

atherosclerosis; zinc and selenium status; rosuvastatin; oxidative stress biomarkers; inflammation biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 months

Secondary Outcomes (3)

• Change from baseline in lipid profile at 4 months

  Baseline and 4 months

• Change from baseline in zinc and selenium status at 4 months

  Baseline and 4 months

• Change from baseline in inflammation biomarkers status at 4 months

  Baseline and 4 months

Study Arms (2)

zinc and selenium supplementation

EXPERIMENTAL

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

Dietary Supplement: zinc and selenium supplementation

rosuvastatin + placebo

PLACEBO COMPARATOR

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

Other: rosuvastatin + placebo

Interventions

zinc and selenium supplementation DIETARY_SUPPLEMENT

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

Also known as: Zinc and selenium supplementation + rosuvastatin

zinc and selenium supplementation

rosuvastatin + placebo OTHER

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

Also known as: placebo group

rosuvastatin + placebo

Eligibility Criteria

• Age: 41 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Onofre Lopes University Hospital

Natal, Rio Grande do Norte, 59.012.300, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25785441 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Zinc; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dulcineia SP Abdalla, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Lucia FC Pedrosa, PhD

  University of Rio Grande do Norte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 7, 2012
• Study Start: January 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

BR (1)