Effect of Magnesium Supplementation on Elevated Systolic Blood Pressure

NCT05690464 | Active Not Recruiting

• 1 other identifier: 2022P002101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

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 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

You may not qualify if:

• 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

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: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 17, 2023
• Primary Completion: March 12, 2025
• Study Completion: May 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)