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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a magnesium glycinate supplement can lower blood pressure over 12 weeks. Participants will receive either the magnesium supplement or a placebo (a pill with no active ingredients) to compare results. The trial seeks individuals with slightly high blood pressure who have not used blood pressure medication before. Those whose blood pressure often reads between 120/80 and 149/94 mmHg may find this trial suitable. Participants should maintain their current diet and limit additional magnesium intake from other supplements to no more than 100 mg daily. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve health.

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.

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

Research has shown that magnesium supplements are usually safe for most people. Studies have found that small doses of magnesium can generally help slightly lower high blood pressure. One source noted that taking between 500 mg and 1000 mg of magnesium daily is linked to a modest decrease in blood pressure.

However, possible side effects should be considered. Some individuals might experience a drop in blood pressure that is too low, especially if they are also taking certain medications. Overall, magnesium glycinate is considered safe for many, with few side effects when taken in recommended amounts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Magnesium glycinate is unique because it offers a potentially natural way to manage high blood pressure. Unlike standard treatments, such as ACE inhibitors, beta-blockers, and diuretics, which can have significant side effects, magnesium glycinate is a dietary supplement that may be easier on the body. Researchers are excited about magnesium's ability to relax blood vessels and improve heart health by addressing magnesium deficiencies, which are common in individuals with high blood pressure. This could mean a more holistic and gentle approach to managing hypertension, with fewer side effects than traditional medications.

What evidence suggests that magnesium glycinate might be an effective treatment for high blood pressure?

Research has shown that magnesium supplements might help lower blood pressure. One study found that taking magnesium reduced the top blood pressure number by about 4.18 points and the bottom number by 2.27 points on average. Another study suggested that taking between 500 mg to 1000 mg of magnesium daily could lower blood pressure by as much as 5.6/2.8 points, though results can vary. In this trial, participants will receive magnesium glycinate, which is being specifically studied. However, a specific study on magnesium glycinate did not show a significant reduction in blood pressure for people with high levels. Despite mixed results, magnesium is believed to have potential benefits for managing blood pressure. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

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

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 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]

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]

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]

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]

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]

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]

Citations

1. 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.

2. 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 ...

3. 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.

4. ahajournals.org ahajournals.org/doi/10.1161/hyp.76.suppl_1.P161

Abstract P161: Randomized Trial Of Magnesium Glycinate ... Conclusions: A Mg glycinate supplement did not significantly reduce seated or 24-h BP in adults with elevated, untreated BP. Forthcoming ...

5. 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 ...

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.