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Magnesium Supplementation and Blood Pressure Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688503
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Pure Encapsulations
Information provided by (Responsible Party):
Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Dietary Supplement: magnesium glycinate supplement Dietary Supplement: placebo Not Applicable

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 40-69 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Untreated High Blood Pressure
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Active Comparator: magnesium
magnesium glycinate supplement, 480 mg/day
Dietary Supplement: magnesium glycinate supplement
magnesium glycinate (480 mg/day)

Placebo Comparator: placebo
placebo supplement
Dietary Supplement: placebo
placebo




Primary Outcome Measures :
  1. Change in seated blood pressure from baseline to 12 weeks [ Time Frame: 12 weeks ]
  2. Change in 24-hour ambulatory blood pressure from baseline to 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in plasma renin activity level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  2. Change in angiotensin II level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  3. Change in aldosterone level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  4. Change in creatinine level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  5. Change in high-sensitivity C-reactive protein level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  6. Change in glucose level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  7. Change in insulin level from baseline to 12 weeks [ Time Frame: 12 weeks ]
  8. Change in hemoglobin A1c level from baseline to 12 weeks [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 35 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688503


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Pure Encapsulations
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Responsible Party: Howard D. Sesso, ScD, MPH, Associate Epidemiologist, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03688503    
Other Study ID Numbers: 2018P-001849
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No