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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

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date August 26, 2020
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Supplementation and Blood Pressure Reduction
Official Title  ICMJE Trial of Magnesium Supplementation and Blood Pressure Reduction Among Adults With Untreated High Blood Pressure
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Blood Pressure
Intervention  ICMJE
  • Dietary Supplement: magnesium glycinate supplement
    magnesium glycinate (480 mg/day)
  • Dietary Supplement: placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: magnesium
    magnesium glycinate supplement, 480 mg/day
    Intervention: Dietary Supplement: magnesium glycinate supplement
  • Placebo Comparator: placebo
    placebo supplement
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 19, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
60
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688503
Other Study ID Numbers  ICMJE 2018P-001849
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Pure Encapsulations
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP