Magnesium Supplementation for High Blood Pressure

Overseen By Leah Arsenault

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Antacids, Laxatives

Disqualifiers: Cardiovascular disease, Cancer, Diabetes, Renal disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a magnesium supplement can lower blood pressure over 12 weeks. Participants will take either a magnesium glycinate supplement or a placebo to determine the supplement's effectiveness. It may suit individuals with moderately high blood pressure, not severe hypertension, who can maintain their current diet and supplement habits. Those who have used magnesium supplements lightly and do not have certain health conditions, such as heart disease or diabetes, may qualify. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of magnesium supplements for managing 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that most people can generally handle magnesium supplements easily. Studies have found that magnesium can help lower blood pressure. These studies typically used doses ranging from 500 mg to 1000 mg per day, similar to the 480 mg/day dose tested in this trial.

Magnesium glycinate, in particular, is gentle on the stomach and less likely to cause digestive problems compared to other forms of magnesium. Although some reports suggest that excessive magnesium might lower blood pressure too much, such cases are rare.

Overall, magnesium supplements are considered safe when taken in recommended amounts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike many standard treatments for high blood pressure, which often include medications like ACE inhibitors or beta-blockers, magnesium glycinate offers a more natural approach by supplementing the body with magnesium. Magnesium is essential for many bodily functions, including muscle relaxation and blood pressure regulation. Researchers are excited about this treatment because it might provide a gentler alternative with fewer side effects, particularly for those looking to manage their blood pressure without traditional pharmaceuticals. Plus, magnesium glycinate is known for its high absorption rate, potentially making it more effective at delivering results compared to other forms of magnesium.

What evidence suggests that magnesium glycinate supplementation could be effective for high blood pressure?

Research has shown that magnesium supplements can help lower blood pressure. Some studies suggest that taking 500 to 1000 mg of magnesium daily might reduce blood pressure by up to 5.6/2.8 mm Hg. One study found that magnesium supplements led to an average drop of 4.18 mm Hg in systolic and 2.27 mm Hg in diastolic blood pressure readings. These findings suggest that magnesium could be useful in managing high blood pressure. Participants in this trial will receive either a magnesium glycinate supplement or a placebo to evaluate its effectiveness in managing high blood pressure. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

Willing to maintain current diet and supplement use patterns during the 12-week intervention period

Your blood pressure is between 130 and 159 when you are sitting down.

You have a systolic blood pressure reading between 125 and 159 mmHg when you measure it yourself.

Exclusion Criteria

I have not had any cancer, except for non-melanoma skin cancer, in the last 5 years.

I have a history of kidney disease.

I have had kidney failure in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person), pre-screening form (online)

Treatment

Participants receive either magnesium glycinate supplement or placebo for 12 weeks

12 weeks

Daily administration, 1 visit (in-person) at 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Glycinate Supplement
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: magnesium Active Control 1 Intervention

magnesium glycinate supplement, 480 mg/day

Group II: placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Pure Encapsulations

Industry Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

Recent evidence from 10 studies, including 5 meta-analyses and 5 randomized controlled trials, suggests that magnesium (Mg) supplementation above the current tolerable upper intake level (UL) of 350 mg/d does not significantly increase the risk of diarrhea in adults.

The analysis indicates that higher doses of magnesium (up to 1200 mg/d) can be safely consumed without major gastrointestinal adverse events, supporting the idea that the UL for magnesium should be re-evaluated to potentially allow for greater supplementation and reduce undernutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Call for Re-evaluation of the Tolerable Upper Intake Level for Magnesium Supplementation in Adults. Costello, R., Rosanoff, A., Nielsen, F., et al.[2023]

A meta-analysis of 34 randomized, double-blind, placebo-controlled trials involving 2028 participants found that magnesium supplementation significantly reduced systolic blood pressure by 2.00 mm Hg and diastolic blood pressure by 1.78 mm Hg over a median duration of 3 months.

The study suggests that a magnesium dose of 300 mg/day for at least 1 month is effective in elevating serum magnesium levels and lowering blood pressure, indicating a potential causal relationship between magnesium supplementation and blood pressure reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Magnesium Supplementation on Blood Pressure: A Meta-Analysis of Randomized Double-Blind Placebo-Controlled Trials. Zhang, X., Li, Y., Del Gobbo, LC., et al.[2022]

Oral magnesium (Mg) supplements can significantly lower blood pressure in Stage 1 hypertension patients, especially when combined with anti-hypertensive medications, with effective doses starting at 230 mg per day for those on long-term medication.

In contrast, magnesium therapy showed no significant blood pressure lowering effects in normotensive individuals, suggesting that higher doses may be necessary for those with hypertension, and highlighting the need for further research on magnesium's role in severe hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium supplements may enhance the effect of antihypertensive medications in stage 1 hypertensive subjects. Rosanoff, A.[2016]

A meta-analysis of seven studies involving 135 hypertensive patients on anti-hypertensive medication showed that oral magnesium supplementation significantly reduced systolic blood pressure by an average of -18.7 mmHg and diastolic blood pressure by -10.9 mmHg, indicating a strong antihypertensive effect.

The results suggest that previous meta-analyses may have underestimated the efficacy of magnesium for hypertension due to mixing different study populations, highlighting the importance of focusing on uniform subsets of studies to accurately assess treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral magnesium supplements decrease high blood pressure (SBP>155 mmHg) in hypertensive subjects on anti-hypertensive medications: a targeted meta-analysis. Rosanoff, A., Plesset, MR.[2020]

In a study involving 17 patients with mild to moderate hypertension, treatment with magnesium aspartate did not lead to a reduction in blood pressure compared to placebo, despite increasing plasma magnesium levels.

The magnesium aspartate was well tolerated without causing side effects like diarrhea, but the findings suggest that dietary magnesium may not play a significant role in managing high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of effect of oral magnesium on high blood pressure: a double blind study. Cappuccio, FP., Markandu, ND., Beynon, GW., et al.[2019]

Magnesium supplementation significantly reduces blood pressure in individuals with preclinical or noncommunicable diseases, with an average decrease of 4.18 mm Hg in systolic blood pressure and 2.27 mm Hg in diastolic blood pressure based on a meta-analysis of 11 randomized controlled trials involving 543 participants.

The analysis showed that magnesium supplementation led to a greater reduction in blood pressure compared to control groups, indicating its potential as an effective intervention for managing blood pressure in those with conditions like insulin resistance and prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dibaba, DT., Xun, P., Song, Y., et al.[2023]

Oral magnesium can effectively lower blood pressure in Uncontrolled Hypertensive patients at doses as low as 240 mg/day, while Untreated Hypertensives require doses greater than 600 mg/day for a significant effect.

In contrast, Controlled Hypertensives and Normotensive individuals do not experience blood pressure reductions with oral magnesium, even at high doses, although other cardiovascular risk factors may improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectively Prescribing Oral Magnesium Therapy for Hypertension: A Categorized Systematic Review of 49 Clinical Trials. Rosanoff, A., Costello, RB., Johnson, GH.[2023]

In a study of 25 mild hypertensive patients over 8 weeks, oral magnesium supplementation did not lower blood pressure compared to a placebo, indicating it may not be effective for this purpose in individuals on a low sodium diet.

While magnesium supplementation increased urinary magnesium and calcium levels significantly, it did not affect plasma magnesium or renin activity, suggesting that magnesium does not enhance blood pressure control in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium supplementation in mild hypertensive patients on a moderately low sodium diet. Nowson, CA., Morgan, TO.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5573024/

The effect of magnesium supplementation on blood ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03688503

Magnesium Supplementation and Blood Pressure Reduction This double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8108907/

The Role of Magnesium in Hypertension and ... Magnesium intake of 500 mg/d to 1000 mg/d may reduce blood pressure (BP) as much as 5.6/2.8 mm Hg. However, clinical studies have a wide range of BP reduction.

4. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.116.07664

Effects of Magnesium Supplementation on Blood Pressure Our data indicated that provision of Mg may slightly lower BP and might be effective in preventing hypertension in the general population.

5. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/mgbp

Understanding the link between magnesium and blood ... The Magnesium and Blood Pressure Trial is investigating how daily magnesium supplements affect blood pressure in adults with elevated blood pressure.

6. mcpress.mayoclinic.org mcpress.mayoclinic.org/nutrition-fitness/magnesium-glycinate-is-this-supplement-helpful-for-you/

Magnesium Glycinate: Is this Supplement Helpful for You? Magnesium supplements are typically well tolerated, especially when you take the supplement in small doses. However, if you ingest high doses of ...

7. ods.od.nih.gov ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/

Magnesium - Health Professional Fact Sheet One example of this claim states, “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-998/magnesium

Magnesium - Uses, Side Effects, and More Magnesium might also block calcium from entering cells. Taking magnesium with these medications might cause blood pressure to go too low.

9. medicalnewstoday.com medicalnewstoday.com/articles/315372

Magnesium glycinate: Benefits, side effects, dosage, and ... High blood pressure: According to an older 2016 study, magnesium supplements can help with high blood pressure by decreasing it slightly.