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OpenTrials
Completed

NCT Number: NCT02837328

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).

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota - Twin Cities

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Magnesium Supplement

Drug

400 mg Magnesium Citrate 1x daily for 12 weeks

Placebo

Drug

Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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