Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

February 22, 2023 updated by: Wen-Chih Wu, Providence VA Medical Center
The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Body mass index greater than 30 kg/m2

Exclusion Criteria:

  1. History of hospitalization for heart failure (systolic or diastolic);
  2. Unstable angina or prior myocardial infarction;
  3. LV ejection fraction <50% on imaging study;
  4. Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
  5. Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30),
  6. Pregnant women or actively breastfeeding women
  7. History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium
20 participants will be treated with 400 mg of Magnesium Oxide twice daily
Dietary supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks
Active Comparator: Comparator
20 participants will receive no treatment
Other: Open label (none)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular mass (by cardiac MRI)
Time Frame: 24 weeks
24 weeks
Left ventricular myocardial triglyceride content (by cardiac MRI)
Time Frame: 24 weeks
24 weeks
Left ventricular extracellular volume fraction (by cardiac MRI)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure
Time Frame: 24 weeks
24 weeks
Aortic pulse wave velocity (by cardiac MRI)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 442702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on 400 mg of Magnesium Oxide twice daily for 24 weeks

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe