Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
1 other identifier
interventional
59
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedResults Posted
Study results publicly available
April 30, 2019
CompletedNovember 1, 2019
October 1, 2019
7 months
June 22, 2016
February 1, 2019
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Premature Atrial Contractions (PACs)
The primary endpoint will be the change in burden of PACs
Change from Baseline at 10 weeks
Secondary Outcomes (1)
Change in Magnesium Concentration
Baseline and week 10
Study Arms (2)
Oral Magnesium Supplement
EXPERIMENTAL400 mg Magnesium Citrate 1x daily for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Interventions
400 mg Magnesium Citrate 1x daily for 12 weeks
Eligibility Criteria
You may qualify if:
- Age 55 and older
- Ability to speak English
- Availability to attend baseline and follow-up visit approximately 12 weeks after baseline
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota - Twin Cities
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
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.
PMID: 32517192DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Lutsey, PhD MPH
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela L Lutsey, PhD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Alvaro Alonso, MD PhD
University of Minnesota
- STUDY CHAIR
Lin Y Chen, MD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 19, 2016
Study Start
March 1, 2017
Primary Completion
September 15, 2017
Study Completion
September 15, 2017
Last Updated
November 1, 2019
Results First Posted
April 30, 2019
Record last verified: 2019-10