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

NCT01151683 | Completed Phase 4

• 1 other identifier: MG600
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Endothelial Dysfunction

Keywords

hypertension; endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• Improvement of vascular function

  six months

Secondary Outcomes (1)

• Improvement of vascular structure and blood pressure

  six months

Study Arms (2)

Magnesium

ACTIVE COMPARATOR

Magnesium chelate 600 mg per day

Dietary Supplement: magnesium

Placebo

PLACEBO COMPARATOR

Placebo 4 capsules per day

Dietary Supplement: placebo

Interventions

magnesium DIETARY_SUPPLEMENT

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

Also known as: Mg supplement

Magnesium

placebo DIETARY_SUPPLEMENT

Two capsules of placebo per oral twice a day

Also known as: Inactive component

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Department of Clinical Medicine, State University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20551030, Brazil

Location

Related Publications (1)

• Cunha AR, Medeiros F, Umbelino B, Oigman W, Touyz RM, Neves MF. Altered vascular structure and wave reflection in hypertensive women with low magnesium levels. J Am Soc Hypertens. 2013 Sep-Oct;7(5):344-52. doi: 10.1016/j.jash.2013.04.008. Epub 2013 Jun 2.

  PMID: 23735418 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Mario F Neves, MD, PhD

  State University of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

BR (1)