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Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

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: NCT02837328
Recruitment Status : Completed
First Posted : July 19, 2016
Results First Posted : April 30, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Premature Atrial Contraction Drug: Oral Magnesium Supplement Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia
Drug Information available for: Magnesium

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




Primary Outcome Measures :
  1. Change in Premature Atrial Contractions (PACs) [ Time Frame: Change from Baseline at 10 weeks ]
    The primary endpoint will be the change in burden of PACs


Secondary Outcome Measures :
  1. Change in Magnesium Concentration [ Time Frame: Baseline and week 10 ]
    The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02837328


Locations
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United States, Minnesota
University of Minnesota - Twin Cities
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
Investigators
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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
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol  [PDF] July 5, 2018
Statistical Analysis Plan  [PDF] July 5, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02837328    
Other Study ID Numbers: 1605M87323
First Posted: July 19, 2016    Key Record Dates
Results First Posted: April 30, 2019
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by University of Minnesota:
Magnesium Supplementation
Magnesium
Dietary Supplement
Arrhythmia
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Atrial Premature Complexes
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature
Cardiac Conduction System Disease