Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Elevated Systolic Blood Pressure
magnesium glycinate supplement
+ placebo
Treatment Study
Summary
Study start date: January 17, 2023
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 74 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location