Magnesium Supplementation and Blood Pressure Reduction

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: magnesium glycinate supplement

Detailed Description

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 40-69 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 35 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

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in plasma renin activity level from baseline to 12 weeks	12 weeks
Change in angiotensin II level from baseline to 12 weeks	12 weeks
Change in aldosterone level from baseline to 12 weeks	12 weeks
Change in creatinine level from baseline to 12 weeks	12 weeks
Change in high-sensitivity C-reactive protein level from baseline to 12 weeks	12 weeks
Change in glucose level from baseline to 12 weeks	12 weeks
Change in insulin level from baseline to 12 weeks	12 weeks
Change in hemoglobin A1c level from baseline to 12 weeks	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018P-001849

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