Blood PressureNCT05690464
Effect of Magnesium Supplementation on Elevated Systolic Blood Pressure
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
The purpose of this study is to assess whether 480 mg/day magnesium glycinate supplementation 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
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
Who cannot join
- 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
Show all 15Show fewer
- 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
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 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.
Read the 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.
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.
- 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 systolic blood pressure from baseline to 12 weeks
Measured: Baseline and 12 week
Change in seated diastolic blood pressure from baseline to 12 weeks
Measured: Baseline and 12 week
Secondary outcomes (3)
Change in serum magnesium levels from baseline to 12 weeks
Measured: Baseline and 12 week
Change in RBC magnesium levels from baseline to 12 weeks
Measured: Baseline and 12 week
Whether the effect of magnesium on seated blood pressure is modified by baseline serum and/or RBC magnesium
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start17 Jan 2023
- Primary completion12 Mar 2025
- Study completionDec 2026 (estimated)
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
- 120 participants (estimated)
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
- NCT05690464
- Sponsor's protocol ID
- 2022P002101
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. 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 Elevated Systolic Blood Pressure
- ClinicalTrials.gov ID
- NCT05690464
- Acronym / sponsor ID
- 2022P002101
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Pure Encapsulations
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jan 2023 (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.
The purpose of this study is to assess whether 480 mg/day magnesium glycinate supplementation for 12 weeks lowers blood pressure.
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.
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 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 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
Key exclusion criteria (15 listed)
- 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
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 systolic blood pressure from baseline to 12 weeks
Time frame: Baseline and 12 week
Change in seated diastolic blood pressure from baseline to 12 weeks
Time frame: Baseline and 12 week
3 secondary outcomes
Change in serum magnesium levels from baseline to 12 weeks
Time frame: Baseline and 12 week
Change in RBC magnesium levels from baseline to 12 weeks
Time frame: Baseline and 12 week
Whether the effect of magnesium on seated blood pressure is modified by baseline serum and/or RBC magnesium
Time frame: Baseline and 12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 systolic blood pressure from baseline to 12 weeks (time frame: Baseline and 12 week). 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 25 Jun 2026.