Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.

NCT04186728

Ventricular Premature Complexes Atrial Premature Complexes

UNKNOWN NA

Role of a Combination of Nutraceuticals (Ritmonutra) on Benign Supraventricular and Ventricular Arrhythmias

NCT01647984

Ventricular and Atrial Extrasytoles

COMPLETED PHASE4

Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study

NCT04768634

Arrhythmia in Children Congenital Heart Disease

TERMINATED NA

Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

NCT01013714

Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation +1 more

RECRUITING PHASE3

Proton Particle Therapy for Cardiac Arrhythmia

NCT04392193

Cardiac Arrhythmia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Atrial Contraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral Magnesium Supplement

400 mg Magnesium Citrate 1x daily for 12 weeks

Group Type EXPERIMENTAL

Oral Magnesium Supplement

Intervention Type DRUG

400 mg Magnesium Citrate 1x daily for 12 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Magnesium Supplement

400 mg Magnesium Citrate 1x daily for 12 weeks

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes