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| Name | Class |
|---|---|
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium | Active Comparator | Magnesium chelate 600 mg per day |
|
| Placebo | Placebo Comparator | Placebo 4 capsules per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium | Dietary Supplement | Magnesium chelate, 300mg (2 capsules of 150mg) twice a day, per oral Total of 600mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of vascular function | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of vascular structure and blood pressure | six months |
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Inclusion Criteria:
Women aged between 40 and 65 years-old
Hypertension with mild blood pressure elevation:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mario F Neves, MD, PhD | State University of Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Medicine, State University of Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | 20551030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23735418 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| placebo | Dietary Supplement | Two capsules of placebo per oral twice a day |
|
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| D008670 |
| Metals |