HypertensionPhase 4MG600NCT01151683
Effects of Magnesium Supplementation on Vascular Structure and Function in Hypertensive Patients
A Phase 4 study testing magnesium in people with Hypertension and Endothelial Dysfunction, run by Rio de Janeiro State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Hypertension, Endothelial Dysfunction
- What is being tested?
- magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Clinical Medicine, State University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20551030
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hypertension, Endothelial Dysfunction
- Being tested
- magnesium, placebo
- Keywords
- hypertension, endothelial dysfunction
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesiumDietary supplement
Also called Mg supplement
Magnesium chelate, 300mg (2 capsules of 150mg) twice a day, per oral Total of 600mg per day
placeboDietary supplement
Also called Inactive component
Two capsules of placebo per oral twice a day
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Active comparator | Magnesium chelate 600 mg per day Receives: Dietary Supplement: magnesium |
| Placebo | Placebo comparator | Placebo 4 capsules per day Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of vascular function
Measured: six months
Secondary outcomes (1)
Improvement of vascular structure and blood pressure
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Mario Fritsch Neves, Rio de Janeiro State University
- Investigators
- Mario F Neves, MD, PhD, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151683
- Sponsor's protocol ID
- MG600
- Acronym
- MG600
- Status last verified
- Jan 2013
- First submitted
- 25 Jun 2010
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23735418
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Supplementation on Vascular Structure and Function in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01151683
- Acronym / sponsor ID
- MG600 / MG600
- Conditions
- Hypertension, Endothelial Dysfunction
- Keywords
- hypertension, endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Active comparator | Dietary Supplement: magnesiumMagnesium chelate 600 mg per day |
| Placebo | Placebo comparator | Dietary Supplement: placeboPlacebo 4 capsules per day |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesiumAlso: Mg supplementMagnesium chelate, 300mg (2 capsules of 150mg) twice a day, per oral Total of 600mg per day | Dietary supplement | Magnesium |
| placeboAlso: Inactive componentTwo capsules of placebo per oral twice a day | Dietary supplement | Placebo |
Primary outcome
Improvement of vascular function
Time frame: six months
1 secondary outcome
Improvement of vascular structure and blood pressure
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Derived from this study: PubMed 23735418Cunha 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario F Neves, MD, PhD principal investigator
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing magnesium in people with Hypertension and Endothelial Dysfunction, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of vascular function (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.