What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, thiazide diuretics, beta blockers, and magnesium supplementation. ACE inhibitors and ARBs can cause side effects such as cough, elevated blood potassium levels, and kidney dysfunction. Calcium channel blockers may lead to swelling, dizziness, and constipation. Thiazide diuretics are associated with electrolyte imbalances, such as low potassium and sodium levels, and can increase the risk of gout. Beta blockers can cause fatigue, cold extremities, and bradycardia. Magnesium supplementation, while generally well-tolerated, can cause gastrointestinal discomfort and diarrhea.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure that improve vascular tone and function. These include calcium channel blockers (CCBs) like amlodipine, which relax blood vessels by inhibiting calcium entry into cells. Angiotensin-converting enzyme (ACE) inhibitors such as lisinopril and angiotensin II receptor blockers (ARBs) like losartan also help by relaxing blood vessels and reducing blood pressure. Additionally, diuretics like indapamide are used to lower blood pressure by reducing fluid volume in the body. These treatments are similar in their vascular effects to the magnesium glycinate being studied for its potential to lower blood pressure.

What other types of research exist?

Promising alternatives to Magnesium Glycinate for high blood pressure treatment include: 1) Sacubitril/Valsartan (an angiotensin receptor-neprilysin inhibitor) which has shown efficacy in reducing blood pressure and improving cardiovascular outcomes. 2) Folic Acid combined with Enalapril, which has been effective in reducing the risk of first stroke in hypertensive patients. 3) Branched-chain amino acids (BCAAs) which have shown potential in improving vascular function. These alternatives offer novel mechanisms and have demonstrated benefits in clinical settings.

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Mineral Supplement

Magnesium Supplementation for High Blood Pressure

N/A

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total magnesium intake from supplements of no more than 100 mg/day

Be older than 18 years old

Must not have

History of renal disease

History of kidney failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Magnesium supplements may cause digestive issues like diarrhea or stomach cramps in some people. High doses might lead to more serious problems such as irregular heartbeat but this is rare especially at controlled doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I take 100 mg or less of magnesium supplements daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of kidney disease.

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I have had kidney failure in the past.

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I have used antacids or laxatives 4 or more times a week in the last 3 months.

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I have been on dialysis.

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I cannot or do not want to swallow 4 pills daily.

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I have a history of heart disease, including heart attack, stroke, or procedures to improve blood flow to my heart.

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I have a history of inflammatory bowel disease.

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I am not pregnant, nursing, or planning to become pregnant during treatment.

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I have a history of diabetes (type 1 or 2).

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I have had pancreatitis before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: magnesiumActive Control1 Intervention

magnesium glycinate supplement, 480 mg/day

Group II: placeboPlacebo Group1 Intervention

placebo supplement

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include ACE inhibitors and ARBs, which relax blood vessels by inhibiting the renin-angiotensin system; calcium channel blockers, which prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels; diuretics, which reduce blood volume by increasing urine output; and beta-blockers, which decrease heart rate and output. Magnesium supplementation, like magnesium glycinate, improves vascular tone and function, potentially lowering blood pressure by relaxing blood vessels and enhancing endothelial function. These mechanisms are crucial for managing high blood pressure as they help reduce the risk of cardiovascular events and organ damage.

Targeting Ouabain- and Adducin-dependent mechanisms of hypertension and cardiovascular remodeling as a novel pharmacological approach.Management of life-threatening autonomic hyper-reflexia using magnesium sulphate in a patient with a high spinal cord injury in the intensive care unit.