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

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ClinicalTrials.gov Identifier: NCT01151683
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : January 7, 2013
Sponsor:
Collaborators:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Mario Fritsch Neves, Rio de Janeiro State University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Endothelial Dysfunction Dietary Supplement: magnesium Dietary Supplement: placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Magnesium Supplementation on Vascular Structure and Function in Hypertensive Patients
Study Start Date : March 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arms and Interventions
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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 Name: Mg supplement
Placebo Comparator: Placebo
Placebo 4 capsules per day
 Dietary Supplement: placebo
Two capsules of placebo per oral twice a day
Other Name: Inactive component


Outcome Measures
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Primary Outcome Measures :
  1. Improvement of vascular function [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Improvement of vascular structure and blood pressure [ Time Frame: six months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151683


Locations
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Brazil
Department of Clinical Medicine, State University of Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 20551030
Sponsors and Collaborators
Rio de Janeiro State University
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Mario F Neves, MD, PhD State University of Rio de Janeiro
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mario Fritsch Neves, Full Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01151683    
Other Study ID Numbers: MG600
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013
Keywords provided by Mario Fritsch Neves, Rio de Janeiro State University:
hypertension
endothelial dysfunction
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases