Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

The primary objective of this research is to determine whether oral magnesium supplementation in healthy, community-living individuals will be associated with reductions in the burden of arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).

Study Overview

• Status: Completed
• Conditions: Premature Atrial Contraction
• Intervention / Treatment: Drug: Oral Magnesium Supplement; Drug: Placebo

Detailed Description

To evaluate the primary objective, the Investigator will conduct a double-blind randomized trial assigning participants to receive 400 mg of oral magnesium in the form of magnesium citrate once daily or placebo. The investigators will recruit 60 individuals 55 years of age and older without a prior history of cardiovascular disease. At baseline, participants will undergo a basic examination, answer questionnaires and provide a blood sample to determine circulating magnesium levels. Participants will then wear an FDA-approved heart rhythm monitor (Zio ® XT Patch) for 2 weeks. At the end of 2 weeks they will begin taking their assigned treatment (magnesium or placebo), and will continue doing so for a total of 12 weeks (through study week 14). After 10 weeks of taking the supplement or placebo (study week 12), they will have a final study visit in which the participants will provide another blood sample for assessment of circulating magnesium, and will be asked to wear the heart rhythm monitor for another 2 weeks (through study week 14). The primary endpoint will be the change in burden of premature atrial contractions (PACs), measured in episodes per day, between baseline and final follow-up visit. A secondary outcome will be the change in circulating magnesium between both exams.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota - Twin Cities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 55 and older
• Ability to speak English
• Availability to attend baseline and follow-up visit approximately 12 weeks after baseline

Exclusion Criteria:

• Prior history of heart disease (coronary heart disease, heart failure, atrial fibrillation), stroke, severe renal disease
• Use of type I and III antiarrhythmics or digoxin
• Current use of magnesium supplements
• Any prior history of allergy or intolerance to magnesium
• Prior history of inflammatory bowel disease or any severe gastrointestinal disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Magnesium Supplement; 400 mg Magnesium Citrate 1x daily for 12 weeks	Drug: Oral Magnesium Supplement; 400 mg Magnesium Citrate 1x daily for 12 weeks
Placebo Comparator: Placebo; Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks	Drug: Placebo; Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Premature Atrial Contractions (PACs)	The primary endpoint will be the change in burden of PACs	Change from Baseline at 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Magnesium Concentration	The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.	Baseline and week 10

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Pamela L Lutsey, PhD, University of Minnesota; Principal Investigator: Alvaro Alonso, MD PhD, University of Minnesota; Study Chair: Lin Y Chen, MD, University of Minnesota

Publications and helpful links

General Publications

• Alonso A, Chen LY, Rudser KD, Norby FL, Rooney MR, Lutsey PL. Effect of Magnesium Supplementation on Circulating Biomarkers of Cardiovascular Disease. Nutrients. 2020 Jun 6;12(6):1697. doi: 10.3390/nu12061697.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Arrhythmia; Magnesium; Dietary Supplement; Magnesium Supplementation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Atrial Premature Complexes
• Other Study ID Numbers: 1605M87323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No