Effects of Magnesium Supplementation on Vascular Structure and Function in Hypertensive Patients

Summary

Introduction: Magnesium has been the target for many experimental and clinical studies due to the negative correlation between its serum and intracellular levels and the prevalence of hypertension and other cardiovascular diseases.

Objective: To evaluate the effects of magnesium supplementation in hypertensive patients who are under diuretic treatment, including correlation of clinical and nutritional parameters with structural and functional aspects of the macrocirculation.

Methods: A prospective, randomized, double blind, placebo controlled study will be performed in hypertensive patients, aged between 40 and 65 years-old, in regular use of thiazidic diuretic as antihypertensive monotherapy,. The patients will be divided in two main groups according to supplementation with placebo or magnesium chelate 300mg twice a day (total of 600mg magnesium element per day). Before and after 3 and 6 months of supplementation, the patients will be submitted to clinical and nutritional evaluation, biochemical analysis, including intracellular magnesium measurement, and study of the macrocirculation with ambulatory blood pressure monitoring, analysis of flow-mediated dilation of brachial artery, measurement of carotid intima-media thickness, and carotid-femoral and carotid-radial pulse wave velocity to estimate central and peripheral arterial stiffness.

Analysis: Data will be expressed as mean±epm. Statistical analysis will be performed using software Prism® (GraphPad, version 5.0). Continuous variables in each group will be compared using "t test", and P\<0.05 will be considered statistically significant.

Conditions

• Hypertension
• Endothelial Dysfunction

Interventions

DIETARY_SUPPLEMENT

magnesium

Magnesium chelate, 300mg (2 capsules of 150mg) twice a day, per oral Total of 600mg per day

DIETARY_SUPPLEMENT

placebo

Two capsules of placebo per oral twice a day

Sponsors & Collaborators

• Rio de Janeiro State Research Supporting Foundation (FAPERJ)

  collaborator OTHER_GOV

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Rio de Janeiro State University

  lead OTHER

Principal Investigators

• Mario F Neves, MD, PhD · State University of Rio de Janeiro

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2012-11-30

Completion

2012-11-30

Countries

• Brazil

Study Locations