Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Overview
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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 15, 2017
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.
Interventions
- Drug: Oral Magnesium Supplement
- 400 mg Magnesium Citrate 1x daily for 12 weeks
- Drug: Placebo
- Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Arms, Groups and Cohorts
- Experimental: 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
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 55 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of Minnesota
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Pamela L Lutsey, PhD, Principal Investigator, University of Minnesota
- Alvaro Alonso, MD PhD, Principal Investigator, University of Minnesota
- Lin Y Chen, MD, Study Chair, University of Minnesota
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.