Effect of Magnesium Supplementation on Elevated Systolic Blood Pressure

Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Elevated Systolic Blood Pressure

The purpose of this study is to assess whether 480 mg/day magnesium glycinate supplementation for 12 weeks lowers blood pressure.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: magnesium glycinate supplement

Detailed Description

This clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure in 120 adults aged 30-74 who have a systolic blood pressure of 130-154 mmHg and are not taking anti-hypertensive medications.

Eligibility to participate in the trial will be determined by a 2-stage screening process. Interested participants will complete a pre-screening form online. If eligibility criteria are met, the potential participants will be scheduled for an in-person screening clinic visit. At the visit, eligible participants will be reminded about the study details and potential risks and will be given the opportunity to sign the Informed Consent. Consented participants will be assigned by chance (like a coin toss) to daily magnesium or to placebo. Participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening) for 12 weeks.

Assessments at the screening visit include seated blood pressure; pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. Participants will return for a clinic visit at 12 weeks to assess these measures.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Howard Sesso, ScD, MPH; Phone Number: 617-278-0803; Email: hsesso@bwh.harvard.edu
• Study Contact Backup: Name: Trisha Copeland, MS, RD; Phone Number: 617-278-0803

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Trisha Copeland, MS, RD; Phone Number: 617-278-0803

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-report of systolic blood pressure 125-159 mmHg
• Measured seated systolic blood pressure 130-159 mmHg at screening visit
• Body mass index less than 40 kg/m2
• Total magnesium intake from supplements of no more than 100 mg/day
• Willing to maintain current diet and supplement use patterns during the 12-week intervention period

Exclusion Criteria:

• Current or past history of anti-hypertensive medication use
• Measured seated diastolic blood pressure 100 mmHg or greater at screening visit
• Antacid or laxative use 4 times/week or more within the past 3 months
• 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 period of treatment
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: magnesium; magnesium glycinate supplement, 480 mg/day	Dietary supplement: magnesium glycinate supplement; magnesium glycinate (480 mg/day)
Placebo Comparator: placebo; placebo supplement	Dietary supplement: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in seated systolic blood pressure from baseline to 12 weeks	Baseline and 12 week
Change in seated diastolic blood pressure from baseline to 12 weeks	Baseline and 12 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in serum magnesium levels from baseline to 12 weeks	Baseline and 12 week
Change in RBC magnesium levels from baseline to 12 weeks	Baseline and 12 week
Whether the effect of magnesium on seated blood pressure is modified by baseline serum and/or RBC magnesium	Baseline and 12 week

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Pure Encapsulations

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: 2022P002101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No