Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Primary Purpose
Premature Atrial Contraction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral Magnesium Supplement
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Premature Atrial Contraction focused on measuring Magnesium Supplementation, Magnesium, Dietary Supplement, Arrhythmia
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
Sites / Locations
- University of Minnesota - Twin Cities
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oral Magnesium Supplement
Placebo
Arm Description
400 mg Magnesium Citrate 1x daily for 12 weeks
Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Outcomes
Primary Outcome Measures
Change in Premature Atrial Contractions (PACs)
The primary endpoint will be the change in burden of PACs
Secondary Outcome Measures
Change in Magnesium Concentration
The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.
Full Information
NCT ID
NCT02837328
First Posted
June 22, 2016
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02837328
Brief Title
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Official Title
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Atrial Contraction
Keywords
Magnesium Supplementation, Magnesium, Dietary Supplement, Arrhythmia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Magnesium Supplement
Arm Type
Experimental
Arm Description
400 mg Magnesium Citrate 1x daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Oral Magnesium Supplement
Intervention Description
400 mg Magnesium Citrate 1x daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Primary Outcome Measure Information:
Title
Change in Premature Atrial Contractions (PACs)
Description
The primary endpoint will be the change in burden of PACs
Time Frame
Change from Baseline at 10 weeks
Secondary Outcome Measure Information:
Title
Change in Magnesium Concentration
Description
The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.
Time Frame
Baseline and week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela L Lutsey, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alvaro Alonso, MD PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lin Y Chen, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota - Twin Cities
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32517192
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.
Results Reference
derived
Learn more about this trial
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
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