Magnesium Supplementation and Blood Pressure Reduction

NCT03688503 | Completed

• 1 other identifier: 2018P-001849
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

magnesium

ACTIVE COMPARATOR

magnesium glycinate supplement, 480 mg/day

Dietary Supplement: magnesium glycinate supplement

placebo

PLACEBO COMPARATOR

placebo supplement

Dietary Supplement: placebo

Interventions

magnesium glycinate supplement DIETARY_SUPPLEMENT

magnesium glycinate (480 mg/day)

magnesium

placebo DIETARY_SUPPLEMENT

placebo

placebo

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Pure Encapsulations: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Epidemiologist, Associate Professor of Medicine

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Study Start: February 15, 2019
• Primary Completion: January 9, 2020
• Study Completion: August 15, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)