Clinical trial NCT02837328: Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Official title: Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Atrial Contraction
Keywords: Magnesium Supplementation
Magnesium
Dietary Supplement
Arrhythmia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 59
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in Premature Atrial Contractions (PACs)
timeFrame: Change from Baseline at 10 weeks
Secondary outcomes:
measure: Change in Magnesium Concentration
timeFrame: Baseline and week 10
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota - Twin Cities
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Pamela L Lutsey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Alvaro Alonso, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Lin Y Chen, MD
role: STUDY_CHAIR
References:
citation: 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.