Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Phase 2

Completed

• Conditions: Premature Atrial Contraction
• Interventions: Drug: Oral Magnesium Supplement; Drug: Placebo

• Registration Number: NCT02837328
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Study Start: 2017-03-01
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Results First Submitted: 2019-02-01
• Results First Submitted QC: 2019-04-11
• Results First Posted: 2019-04-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Magnesium Supplement	Oral Magnesium Supplement	400 mg Magnesium Citrate 1x daily for 12 weeks
Placebo	Placebo	Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in Premature Atrial Contractions (PACs)	Change from Baseline at 10 weeks	The primary endpoint will be the change in burden of PACs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota - Twin Cities; 🇺🇸 Minneapolis, Minnesota, United States