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CompletedNCT02966912Updated Feb 24, 2023

Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity

An interventional study of 400 mg of Magnesium Oxide twice daily for 24 weeks and Open label (none) in Obesity, sponsored by Providence VA Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.

Sponsored by Providence VA Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Obesity
03

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Body mass index greater than 30 kg/m2

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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)

Interventions

  • Dietary supplement400 mg of Magnesium Oxide twice daily for 24 weeks
  • OtherOpen label (none)
05

What researchers measure

Primary outcomes

  1. Left ventricular mass (by cardiac MRI)

    Time frame: 24 weeks

  2. Left ventricular myocardial triglyceride content (by cardiac MRI)

    Time frame: 24 weeks

  3. Left ventricular extracellular volume fraction (by cardiac MRI)

    Time frame: 24 weeks

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 24 weeks

  2. Aortic pulse wave velocity (by cardiac MRI)

    Time frame: 24 weeks

06

Study locations

1 site
  • Providence VA Medical Center
    Providence, Rhode Island 02908, United States
07

Registry details

Key details

Study ID
NCT02966912
Lead sponsor
Providence VA Medical Center
Responsible party
Wen-Chih Wu (Chief of Medicine at the PVAMC and Professor of Medicine at Brown University, Providence VA Medical Center) — Principal investigator
First posted
Nov 17, 2016
Start date
Nov 2016
Primary completion
Mar 2019
Completion
Sep 2019
Last update
Feb 24, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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