Magnesium Supplements for High Blood Pressure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Antihypertensives, Antacids, Laxatives

Disqualifiers: Cardiovascular disease, Diabetes, Renal disease, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

59 Participants Needed

Trial Summary

What is the purpose of this trial?

This double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers 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 maintain your current diet and supplement use patterns during the study.

What data supports the effectiveness of the treatment Magnesium Glycinate Supplement for high blood pressure?

Research shows that magnesium supplements can lower blood pressure, with one study finding a reduction of 2.00 mm Hg in systolic and 1.78 mm Hg in diastolic blood pressure. Another study found that magnesium supplements significantly reduced blood pressure in people with insulin resistance or prediabetes. ^{1 2 3 4 5}

Is 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, but caution is advised for those with kidney problems. ^{1 2 6 7 8}

How does the treatment Magnesium Glycinate Supplement differ from other treatments for high blood pressure?

Magnesium Glycinate Supplement is unique because it may enhance the effect of existing antihypertensive medications, particularly in patients with uncontrolled high blood pressure, and can safely lower blood pressure without the side effects associated with traditional medications. It is also noted for its potential to improve other cardiovascular risk factors even when it does not significantly lower blood pressure. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for adults with high blood pressure (systolic 120-149 mmHg or diastolic 80-94 mmHg) who are willing to keep their diet and supplement intake the same during the study. They must have a BMI under 35, not take more than 100 mg/day of magnesium supplements, and cannot be planning to move out of Boston within a year.

Inclusion Criteria

I take 100 mg or less of magnesium supplements daily.

Body mass index less than 35 kg/m2

Self-report of systolic blood pressure 120-139 mmHg or diastolic blood pressure 80-89 mmHg at prescreening

Exclusion Criteria

I am unable to sign a consent form.

History of hypermagnesemia

I cannot or will not take 4 pills daily.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Treatment

Participants receive either magnesium glycinate supplement or placebo for 12 weeks

12 weeks

2 visits (in-person at 6 and 12 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Magnesium Glycinate Supplement
• Placebo

Trial Overview The trial is testing if taking magnesium glycinate (480 mg/day) for three months can lower blood pressure. Participants will either receive this supplement or a placebo without knowing which one they're getting.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

Physiological oral magnesium supplementation is safe and effective for treating magnesium deficiencies, while pharmacological magnesium therapy can lead to toxicity and should be used cautiously, particularly in acute settings.

Magnesium therapy has specific applications in obstetrics, cardiology, and anesthesia, such as treating eclampsia and certain heart rhythm disorders, but requires careful monitoring to avoid complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium and therapeutics. Durlach, J., Durlach, V., Bac, P., et al.[2017]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Magnesium Supplementation on Blood Pressure: A Meta-Analysis of Randomized Double-Blind Placebo-Controlled Trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Lack of effect of oral magnesium on high blood pressure: a double blind study. [2019]

3. England 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Perspective: Call for Re-evaluation of the Tolerable Upper Intake Level for Magnesium Supplementation in Adults. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Magnesium and therapeutics. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectively Prescribing Oral Magnesium Therapy for Hypertension: A Categorized Systematic Review of 49 Clinical Trials. [2023]