Blood PressureNCT03688503
Magnesium Supplementation and Blood Pressure Reduction
A study testing magnesium glycinate supplement in people with Blood Pressure, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- magnesium glycinate supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Blood Pressure
- Being tested
- magnesium glycinate supplement, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium glycinate supplementDietary supplement
magnesium glycinate (480 mg/day)
placeboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| magnesium | Active comparator | magnesium glycinate supplement, 480 mg/day Receives: Dietary Supplement: magnesium glycinate supplement |
| placebo | Placebo comparator | placebo supplement Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in seated blood pressure from baseline to 12 weeks
Measured: 12 weeks
Change in 24-hour ambulatory blood pressure from baseline to 12 weeks
Measured: 12 weeks
Secondary outcomes (11)
Change in plasma renin activity level from baseline to 12 weeks
Measured: 12 weeks
Change in angiotensin II level from baseline to 12 weeks
Measured: 12 weeks
Change in aldosterone level from baseline to 12 weeks
Measured: 12 weeks
Change in creatinine level from baseline to 12 weeks
Measured: 12 weeks
Change in high-sensitivity C-reactive protein level from baseline to 12 weeks
Measured: 12 weeks
Change in glucose level from baseline to 12 weeks
Measured: 12 weeks
Change in insulin level from baseline to 12 weeks
Measured: 12 weeks
Change in hemoglobin A1c level from baseline to 12 weeks
Measured: 12 weeks
Change in interleukin-6 level from baseline to 12 weeks
Measured: 12 weeks
Change in serum magnesium levels from baseline to 12 weeks
Measured: 12 weeks
Whether the baseline magnesium status modifies the effect on seated and 24-hour ambulatory BP
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start15 Feb 2019
- Primary completion9 Jan 2020
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pure Encapsulations
- Responsible party
- Principal investigator, Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688503
- Sponsor's protocol ID
- 2018P-001849
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Untreated High Blood Pressure
- ClinicalTrials.gov ID
- NCT03688503
- Acronym / sponsor ID
- 2018P-001849
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Pure Encapsulations
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium | Active comparator | Dietary Supplement: magnesium glycinate supplementmagnesium glycinate supplement, 480 mg/day |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo supplement |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium glycinate supplementmagnesium glycinate (480 mg/day) | Dietary supplement | magnesium |
| placeboplacebo | Dietary supplement | placebo |
Primary outcome
Change in seated blood pressure from baseline to 12 weeks
Time frame: 12 weeks
Change in 24-hour ambulatory blood pressure from baseline to 12 weeks
Time frame: 12 weeks
11 secondary outcomes
Change in plasma renin activity level from baseline to 12 weeks
Time frame: 12 weeks
Change in angiotensin II level from baseline to 12 weeks
Time frame: 12 weeks
Change in aldosterone level from baseline to 12 weeks
Time frame: 12 weeks
Change in creatinine level from baseline to 12 weeks
Time frame: 12 weeks
Change in high-sensitivity C-reactive protein level from baseline to 12 weeks
Time frame: 12 weeks
Change in glucose level from baseline to 12 weeks
Time frame: 12 weeks
Change in insulin level from baseline to 12 weeks
Time frame: 12 weeks
Change in hemoglobin A1c level from baseline to 12 weeks
Time frame: 12 weeks
Change in interleukin-6 level from baseline to 12 weeks
Time frame: 12 weeks
Change in serum magnesium levels from baseline to 12 weeks
Time frame: 12 weeks
Whether the baseline magnesium status modifies the effect on seated and 24-hour ambulatory BP
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium glycinate supplement in people with Blood Pressure, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seated blood pressure from baseline to 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.