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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Magnesium Supplement | Experimental | 400 mg Magnesium Citrate 1x daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Magnesium Supplement | Drug | 400 mg Magnesium Citrate 1x daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Premature Atrial Contractions (PACs) | The primary endpoint will be the change in burden of PACs | Change from Baseline at 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Magnesium Concentration | The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later. | Baseline and week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela L Lutsey, PhD | University of Minnesota | Principal Investigator |
| Alvaro Alonso, MD PhD | University of Minnesota | Principal Investigator |
| Lin Y Chen, MD | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota - Twin Cities | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32517192 | Derived | 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. |
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Participants attended a baseline visit where measurements were conducted and a Zio XT Patch heart rhythm monitor was applied by trained staff. After wearing the patch for 2 weeks, the participants were randomized 1:1 to either magnesium oxide or a placebo using block randomization within two strata of age (younger than 65 and 65 and older).
Participants of 55 years of age or older were recruited using fliers, the University of Minnesota StudyFinder website, invitations to individuals enrolled in the ResearchMatch research volunteer database, and invitations to University of Minnesota School of Public Health employees.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Magnesium Supplement | 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks |
| FG001 | Placebo | Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Magnesium Supplement | 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks |
| BG001 | Placebo | Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Premature Atrial Contractions (PACs) | The primary endpoint will be the change in burden of PACs | Posted | Mean | Standard Deviation | Episodes/hour | Change from Baseline at 10 weeks |
|
59 days, from day 21 of the intervention to day 80
Participants were asked an open-ended question about the occurrence of adverse events. Adverse event information was collected in such a way that individual adverse event terms cannot be separated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Magnesium Supplement | 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Symptoms | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Lutsey, PhD MPH | University of Minnesota | 612-624-5812 | lutsey@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2018 | Apr 3, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2018 | Apr 3, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018880 | Atrial Premature Complexes |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| Placebo | Drug | Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum Magnesium Concentrations | Mean | Standard Deviation | mEq/L |
|
| Premature Arterial Contractions Burden | Mean | Standard Deviation | episode/hour |
|
| Log Premature Arterial Contractions Burden | Mean | Standard Deviation | log(Episodes/hour) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Magnesium Concentration | The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later. | Posted | Mean | Standard Deviation | mEq/L | Baseline and week 10 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 15 |
| 29 |
| EG001 | Placebo | Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks Placebo: Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks | 0 | 30 | 0 | 30 | 2 | 30 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |