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

Must not be taking: Antacids, Laxatives

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

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. ^{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. ^{2 4 6 7 8}

How 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. ^{1 2 3 4 6}

Research Team

Eligibility 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

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.

Trial Timeline

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

Treatment Details

Interventions

• Magnesium Glycinate Supplement (Mineral Supplement)
• Placebo (Behavioural Intervention)

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.

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 Canada for the following indications:

Approved in Canada 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+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Pure Encapsulations

Industry Sponsor

Trials

2

Recruited

180+

Findings from Research

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]

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]

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]

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]

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]

References

1. 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]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. Australia pubmed.ncbi.nlm.nih.gov

Magnesium supplementation in mild hypertensive patients on a moderately low sodium diet. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

8. England pubmed.ncbi.nlm.nih.gov

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