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Completed

NCT Number: 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 pressure.

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Key information

Conditions

Age range

30 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

About this study

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 in 60 adults aged 30-74 who have elevated blood pressure or stage 1 hypertension and are not taking anti-hypertensive medication. Animal studies, epidemiologic studies, and small randomized trials suggest that supplemental Mg may reduce blood pressure, but the evidence is not definitive.

Eligibility to participate in the trial will be determined by a 2-stage screening process -- completion of a pre-screening form online followed by an in-person screening clinic visit. Eligible participants will assigned by chance (like a coin toss) to daily magnesium or to placebo and will receive a supply of study capsules via U.S. mail. Participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening).

Assessments at the screening visit include seated blood pressure; 24-hour ambulatory blood pressure (monitor will be worn by the participant for 24 hours and then returned via mail); pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. Participants will return for clinic visits at 6 weeks and at 12 weeks to assess these measures, including 24-hour ambulatory blood pressure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-report of systolic blood pressure 120-139 mmHg or diastolic blood pressure 80-89 mmHg at prescreening
  • Measured seated systolic blood pressure 120-149 mmHg or measured seated diastolic blood pressure 80-94 mmHg at screening visit
  • Body mass index less than 40 kg/m2
  • Total Mg intake from supplements of no more than 100 mg/day
  • Willing to maintain current diet and supplement use patterns during the intervention period

Exclusion criteria

  • History of antihypertensive use
  • History of cardiovascular disease (myocardial infarction, stroke, revascularization [coronary artery bypass graft or percutaneous transluminal coronary angioplasty], or angina pectoris)
  • History of invasive cancer diagnosed within the last 5 years (non-melanoma skin cancer permitted)
  • History of type 1 or 2 diabetes
  • History of renal disease
  • History of kidney failure
  • History of dialysis
  • History of pancreatitis
  • History of inflammatory bowel disease
  • History of hypermagnesemia
  • Women who are pregnant, nursing, or intend to become pregnant during the treatment period
  • Plan to relocate out of Boston area within the next year
  • Unwillingness and/or inability to swallow 4 pills per day
  • Inability to provide written informed consent
  • Excessive antacid or laxative use within the past 3 months

Treatment and study plan

magnesium glycinate supplement

Dietary Supplement

magnesium glycinate (480 mg/day)

Placebo

Dietary Supplement

placebo

Primary outcomes

  1. Change in seated blood pressure from baseline to 12 weeks

    Time frame: 12 weeks

  2. Change in 24-hour ambulatory blood pressure from baseline to 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. Change in plasma renin activity level from baseline to 12 weeks

    Time frame: 12 weeks

  2. Change in angiotensin II level from baseline to 12 weeks

    Time frame: 12 weeks

  3. Change in aldosterone level from baseline to 12 weeks

    Time frame: 12 weeks

  4. Change in creatinine level from baseline to 12 weeks

    Time frame: 12 weeks

  5. Change in high-sensitivity C-reactive protein level from baseline to 12 weeks

    Time frame: 12 weeks

  6. Change in glucose level from baseline to 12 weeks

    Time frame: 12 weeks

  7. Change in insulin level from baseline to 12 weeks

    Time frame: 12 weeks

  8. Change in hemoglobin A1c level from baseline to 12 weeks

    Time frame: 12 weeks

  9. Change in interleukin-6 level from baseline to 12 weeks

    Time frame: 12 weeks

  10. Change in serum magnesium levels from baseline to 12 weeks

    Time frame: 12 weeks

  11. Whether the baseline magnesium status modifies the effect on seated and 24-hour ambulatory BP

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Pure Encapsulations

Registry information

Official study title

Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Untreated High Blood Pressure

Important dates

Study start
2019
Primary completion
2020
Study completion
2025
First posted
Sep 28, 2018
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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