Magnesium Supplementation for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing if taking a daily magnesium supplement for a few months can lower blood pressure in adults aged 30-74 with slightly high blood pressure. Magnesium helps relax blood vessels, which may help reduce blood pressure. Magnesium supplementation has been studied for over 25 years with inconsistent results in lowering blood pressure.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be willing to keep your current diet and supplement use the same during the study.
What data supports the effectiveness of the drug Magnesium Glycinate Supplement for high blood pressure?
Research shows that magnesium supplements can lower blood pressure, especially in people already taking blood pressure medications. A meta-analysis found that magnesium reduced systolic blood pressure by an average of 18.7 mmHg in certain high blood pressure patients.
12345Is magnesium supplementation safe for humans?
Magnesium supplements are generally safe for humans, with diarrhea being the most common side effect at high doses. Studies show that doses above the current recommended limit can be consumed without significant adverse effects.
24678How does magnesium glycinate supplementation differ from other treatments for high blood pressure?
Magnesium glycinate supplementation is unique because it can enhance the effect of existing blood pressure medications, especially in individuals with uncontrolled hypertension, and may require lower doses compared to other forms of magnesium to achieve blood pressure reduction. It also offers potential benefits without the side effects associated with traditional antihypertensive drugs.
12346Eligibility Criteria
This trial is for adults with a self-reported systolic blood pressure between 125-159 mmHg and measured seated systolic blood pressure of 130-159 mmHg. Participants should have a BMI under 40, take no more than 100 mg/day of magnesium from supplements, and be willing to keep their diet the same during the study. People with severe high blood pressure, certain chronic diseases, or those who are pregnant or planning to move away can't join.Inclusion Criteria
I take 100 mg or less of magnesium supplements daily.
Exclusion Criteria
I have a history of kidney disease.
I have had kidney failure in the past.
I have used antacids or laxatives 4 or more times a week in the last 3 months.
I have been on dialysis.
I cannot or do not want to swallow 4 pills daily.
I have a history of heart disease, including heart attack, stroke, or procedures to improve blood flow to my heart.
I have a history of inflammatory bowel disease.
I am not pregnant, nursing, or planning to become pregnant during treatment.
I have a history of diabetes (type 1 or 2).
I have had pancreatitis before.
Participant Groups
The trial is testing if taking a daily dose of magnesium glycinate (480 mg) for three months can lower high systolic blood pressure compared to a placebo. The participants will either receive the supplement or an inactive pill without knowing which one they're getting.
2Treatment groups
Active Control
Placebo Group
Group I: magnesiumActive Control1 Intervention
magnesium glycinate supplement, 480 mg/day
Group II: placeboPlacebo Group1 Intervention
placebo supplement
Magnesium Glycinate Supplement is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Magnesium Glycinate for:
- Dietary Supplementation
🇨🇦 Approved in Canada as Magnesium Glycinate for:
- Dietary Supplementation
🇪🇺 Approved in European Union as Magnesium Glycinate for:
- Dietary Supplementation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
Pure EncapsulationsIndustry Sponsor
References
Oral magnesium supplements decrease high blood pressure (SBP>155 mmHg) in hypertensive subjects on anti-hypertensive medications: a targeted meta-analysis. [2020]Previously, we examined 44 human studies involving oral magnesium (Mg) supplementation for hypertension (HT), sorting them according to HT status, Mg dose and anti-hypertensive medication usage. We found that while some studies reported a significant lowering of blood pressure with Mg supplementation, others did not. We present here our first meta-analysis of a uniform subset from this series of studies. Seven studies, involving 135 hypertensive subjects on anti-hypertensive medication continuously for at least six months, with no more than a two-week washout and with a mean starting systolic blood pressure (SBP)>155 mmHg, demonstrated a mean change of -18.7 mmHg [95% CI=-14.95 to -22.45] p155 mmHg starting SBP values or not complying as regards anti-hypertensive medication usage, showed mean changes in both SBP and DBP with oral Mg that, while not approaching the high-responder values of the present study, appeared to include some high-responder subjects combined with low- or non-responder subjects. This uniform subset of seven studies showed a strong effect of Mg treatment in hypertension, which is in stark contrast to results of three other meta-analyses. Using non-uniform sets of studies, the small effects reported in previous meta-analyses may reflect a blending of dissimilar studies, which acted to seriously underestimate the potential of Mg in hypertension in some (but not all) subjects. Within studies, blending of non-, moderate and highresponder subjects in any one study might mask strong effects of Mg treatment in some subjects.
Effects of Magnesium Supplementation on Blood Pressure: A Meta-Analysis of Randomized Double-Blind Placebo-Controlled Trials. [2022]The antihypertensive effect of magnesium (Mg) supplementation remains controversial. We aimed to quantify the effect of oral Mg supplementation on blood pressure (BP) by synthesizing available evidence from randomized, double-blind, placebo-controlled trials. We searched trials of Mg supplementation on normotensive and hypertensive adults published up to February 1, 2016 from MEDLINE and EMBASE databases; 34 trials involving 2028 participants were eligible for this meta-analysis. Weighted mean differences of changes in BP and serum Mg were calculated by random-effects meta-analysis. Mg supplementation at a median dose of 368 mg/d for a median duration of 3 months significantly reduced systolic BP by 2.00 mm Hg (95% confidence interval, 0.43-3.58) and diastolic BP by 1.78 mm Hg (95% confidence interval, 0.73-2.82); these reductions were accompanied by 0.05 mmol/L (95% confidence interval, 0.03, 0.07) elevation of serum Mg compared with placebo. Using a restricted cubic spline curve, we found that Mg supplementation with a dose of 300 mg/d or duration of 1 month is sufficient to elevate serum Mg and reduce BP; and serum Mg was negatively associated with diastolic BP but not systolic BP (all P
Magnesium supplements may enhance the effect of antihypertensive medications in stage 1 hypertensive subjects. [2016]Comprehensive analytical review of 44 human studies in 43 publications of oral Magnesium (Mg) therapy for hypertension (HT) shows Mg supplements may enhance the blood-pressure (BP) lowering effect of anti-hypertensive medications (medications) in Stage 1 HT subjects. 9 studies conducted on subjects treated with medications continuously >/= 6 months (with /= 4 weeks within 6 months pre-study. Of the 4 remaining studies showing no BP change at these high Mg doses, two had large placebo effect, a third one had significant baseline discrepancies between Mg-test and placebo groups, and the fourth showed a significant decrease in DBP but not SBP. Thirteen studies on normotensive subjects, both treated and untreated with medications, showed no significant BP lowering effect with oral Mg therapy up to 25 mmol/day (607 mg).
The effect of magnesium supplementation on blood pressure in individuals with insulin resistance, prediabetes, or noncommunicable chronic diseases: a meta-analysis of randomized controlled trials. [2023]Background: To our knowledge, the effect of magnesium supplementation on blood pressure (BP) in individuals with preclinical or noncommunicable diseases has not been previously investigated in a meta-analysis, and the findings from randomized controlled trials (RCTs) have been inconsistent.Objective: We sought to determine the pooled effect of magnesium supplementation on BP in participants with preclinical or noncommunicable diseases.Design: We identified RCTs that were published in English before May 2017 that examined the effect of magnesium supplementation on BP in individuals with preclinical or noncommunicable diseases through PubMed, ScienceDirect, Cochrane, clinicaltrials.gov, SpringerLink, and Google Scholar databases as well as the reference lists from identified relevant articles. Random- and fixed-effects models were used to estimate the pooled standardized mean differences (SMDs) with 95% CIs in changes in BP from baseline to the end of the trial in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) between the magnesium-supplementation group and the control group.Results: Eleven RCTs that included 543 participants with follow-up periods that ranged from 1 to 6 mo (mean: 3.6 mo) were included in this meta-analysis. The dose of elemental magnesium that was used in the trials ranged from 365 to 450 mg/d. All studies reported BP at baseline and the end of the trial. The weighted overall effects indicated that the magnesium-supplementation group had a significantly greater reduction in both SBP (SMD: -0.20; 95% CI: -0.37, -0.03) and DBP (SMD: -0.27; 95% CI: -0.52, -0.03) than did the control group. Magnesium supplementation resulted in a mean reduction of 4.18 mm Hg in SBP and 2.27 mm Hg in DBP.Conclusion: The pooled results suggest that magnesium supplementation significantly lowers BP in individuals with insulin resistance, prediabetes, or other noncommunicable chronic diseases.
Magnesium supplementation in mild hypertensive patients on a moderately low sodium diet. [2019]1. The effect of oral magnesium supplementation was assessed in a group of untreated, mild hypertensive subjects who were following a moderately low sodium diet (baseline urinary sodium 86 +/- 6 mmol/day). 2. Thirteen patients were allocated placebo and 12 were allocated magnesium aspartate (10 mmol/day) in a double blind fashion for 8 weeks. 3. There was no fall in blood pressure with magnesium supplementation and no significant difference in blood pressure between groups at the end of the study. 4. In the magnesium group there was an increase in urinary magnesium (4.4 +/- 0.6 to 6.1 +/- 1 mmol/day P less than 0.001), and urinary calcium (4.3 +/- 0.7 to 5.5 +/- 0.9 mmol/day P less than 0.01). There was no change in plasma or red cell magnesium or plasma renin activity with supplementation. 5. Magnesium supplementation does not appear to have an additive hypotensive effect in mild hypertensive subjects on a reduced sodium intake.
Effectively Prescribing Oral Magnesium Therapy for Hypertension: A Categorized Systematic Review of 49 Clinical Trials. [2023]Trials and meta-analyses of oral magnesium for hypertension show promising but conflicting results. An inclusive collection of 49 oral magnesium for blood pressure (BP) trials were categorized into four groups: (1) Untreated Hypertensives; (2) Uncontrolled Hypertensives; (3) Controlled Hypertensives; (4) Normotensive subjects. Each group was tabulated by ascending magnesium dose. Studies reporting statistically significant (p < 0.05) decreases in both systolic BP (SBP) and diastolic BP (DBP) from both baseline and placebo (if reported) were labeled "Decrease"; all others were deemed "No Change." Results: Studies of Untreated Hypertensives (20 studies) showed BP "Decrease" only when Mg dose was >600 mg/day; <50% of the studies at 120-486 mg Mg/day showed SBP or DBP decreases but not both while others at this Mg dosage showed no change in either BP measure. In contrast, all magnesium doses (240-607 mg/day) showed "Decrease" in 10 studies on Uncontrolled Hypertensives. Controlled Hypertensives, Normotensives and "magnesium-replete" studies showed "No Change" even at high magnesium doses (>600 mg/day). Where magnesium did not lower BP, other cardiovascular risk factors showed improvement. Conclusion: Controlled Hypertensives and Normotensives do not show a BP-lowering effect with oral Mg therapy, but oral magnesium (≥240 mg/day) safely lowers BP in Uncontrolled Hypertensive patients taking antihypertensive medications, while >600 mg/day magnesium is required to safely lower BP in Untreated Hypertensives; <600 mg/day for non-medicated hypertensives may not lower both SBP and DBP but may safely achieve other risk factor improvements without antihypertensive medication side effects.
Perspective: Call for Re-evaluation of the Tolerable Upper Intake Level for Magnesium Supplementation in Adults. [2023]In 1997, the US Institute of Medicine (IOM) dietary reference intakes (DRI) Committee established a magnesium (Mg) tolerable upper intake level (UL) for adults of 350 mg/d from supplemental intake alone. Diarrhea was the limiting factor. The safety of oral Mg dietary supplements exceeding the UL is currently in debate. Increasing the UL may result in more Mg supplementation, decreasing the prevalence of undernutrition for this nutrient and thus providing additional protection against numerous chronic diseases. This perspective aims to show that more recent and comprehensive evidence-based data on the occurrence of diarrhea indicate that the Mg UL for adults should be re-evaluated. To update the literature base to re-evaluate setting the Mg UL, a PubMed search was conducted to identify intervention studies published between 1997 and 2022 that used single-ingredient Mg products reporting a priori diarrhea adverse events among adults. The Food and Drug Administration Center for Food Safety and Adverse Event Reporting System (CAERS) was also searched for adverse events caused by Mg supplementation. The PubMed search identified 10 studies, including 5 meta-analyses and 5 randomized controlled trials, that met the search criteria. Seven studies (Mg intakes of 128-1200 mg/d) found no significant differences in diarrhea occurrence between the intervention and control groups. One meta-analysis found only minor differences in gastrointestinal disturbances between groups given placebo versus 520 mg Mg/d, but withdrawals were not significantly different between groups. Another meta-analysis found that 3 of 13 studies (120-973 mg/d) reported diarrhea that led to study withdrawal, but the treatment arm was not specified in 2 studies. The CAERS search, when limited to single-ingredient suspect Mg products, found only 40 attributable cases of gastrointestinal adverse events. Only one-third of these 40 cases noted a complaint of diarrhea. These updated data indicate that doses above the current UL for Mg supplements can be consumed without adverse events.
Lack of effect of oral magnesium on high blood pressure: a double blind study. [2019]Seventeen unselected patients with mild to moderate essential hypertension and whose average supine blood pressure after two months' observation with no treatment was 154/100 mm Hg were entered into a double blind randomised crossover study of one month's treatment with magnesium aspartate (15 mmol magnesium/day) and treatment with placebo for a further month. This preparation of magnesium was well tolerated and did not cause diarrhoea. Despite a significant increase in plasma magnesium concentration and a significant increase in urinary excretion of magnesium while taking magnesium aspartate there was no fall in blood pressure compared with either treatment with placebo or values before treatment. The results provide no evidence for a role of dietary magnesium in the regulation of high blood pressure and are contrary to recent speculations.