Effects of Magnesium Supplementation on Vascular Structure and Function in Hypertensive Patients (MG600)

January 4, 2013 updated by: Mario Fritsch Neves, Rio de Janeiro State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to evaluate whether magnesium supplementation is associated with improved blood pressure control and whether it has beneficial effects on the vascular structure and function in non-diabetic hypertensive patients who are receiving r diuretic therapy.

Patients will be evaluated in a prospective, randomized, double-blind study and will be admitted to the study if they reach all the inclusion criteria and no exclusion criteria.

In this study, magnesium chelate was chosen because of its better absorption rate. The dosages are different in many protocols but in this project the patients will receive 600 mg of magnesium element daily divided in 300 mg twice a day. 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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20551030
        • Department of Clinical Medicine, State University of Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged between 40 and 65 years-old

  • Hypertension with mild blood pressure elevation:

    • Systolic BP between 140 and 159mmHg AND/OR
    • Diastolic BP between 90 and 99 mmHg
  • Antihypertensive monotherapy with daily use of thiazidic diuretic, at least in the last 30 days
  • Signature of the Informed Consent by the patient or his legal representative

Exclusion Criteria:

  • Evidences for secondary hypertension
  • Hypertension in stage 2, SBP ≥ 160mmHg and/or DBP ≥ 100mmHg, before the beginning of supplementation
  • Blood pressure > 180 x 100 mmHg in any phase of the study
  • Body mass index > 35 kg/m2
  • Diabetes Mellitus
  • Renal disease presenting glomerular filtration rate < 60ml/min
  • Coronary artery disease clinically evident with previous episode of myocardial infarction and/or myocardial revascularization
  • Clinical signs of heart failure
  • History of stroke
  • Any condition, disease or therapy that, under investigator's opinion, may influence objectives, results, or put in risk the safety of the patients.
  • Pregnancy
  • Patients should not be taking any mineral or vitamin supplements
  • Gastrointestinal conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium
Magnesium chelate 600 mg per day
Dietary supplement: magnesium
Magnesium chelate, 300mg (2 capsules of 150mg) twice a day, per oral Total of 600mg per day
Other Names:
  • Mg supplement
Placebo Comparator: Placebo
Placebo 4 capsules per day
Dietary supplement: placebo
Two capsules of placebo per oral twice a day
Other Names:
  • Inactive component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of vascular function
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of vascular structure and blood pressure
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Mario F Neves, MD, PhD, State University of Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 25, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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