Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

• ClinicalTrials.gov Identifier: NCT02837328
• Recruitment Status: Completed
• First Posted: July 19, 2016
• Results First Posted: April 30, 2019
• Last Update Posted: November 1, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Premature Atrial Contraction
• Interventions: Drug: Oral Magnesium Supplement; Drug: Placebo
• Enrollment: 59

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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).

Arm/Group Title	Oral Magnesium Supplement	Placebo
Arm/Group Description	400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	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
Period Title: Overall Study
Started	29	30
Completed	29	30
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Oral Magnesium Supplement	Placebo	Total
Arm/Group Description		400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	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	Total of all reporting groups
Overall Number of Baseline Participants		29	30	59
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	30 participants	59 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	23 79.3%	22 73.3%	45 76.3%
	>=65 years	6 20.7%	8 26.7%	14 23.7%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	29 participants	30 participants	59 participants
		61.3 (5.3)	61.6 (5.2)	61.5 (5.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	30 participants	59 participants
	Female	25 86.2%	18 60.0%	43 72.9%
	Male	4 13.8%	12 40.0%	16 27.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race/Ethnicity	Number Analyzed	29 participants	30 participants	59 participants
	White	27 93.1%	29 96.7%	56 94.9%
	Non-White	2 6.9%	1 3.3%	3 5.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	29 participants	30 participants	59 participants
		29	30	59
Serum Magnesium Concentrations; Mean (Standard Deviation); Unit of measure: mEq/L
	Number Analyzed	29 participants	30 participants	59 participants
		1.74 (0.12)	1.71 (.1)	1.72 (0.11)
Premature Arterial Contractions Burden; Mean (Standard Deviation); Unit of measure: Episode/hour
	Number Analyzed	29 participants	30 participants	59 participants
		8.5 (14)	20.2 (80)	14.5 (58)
Log Premature Arterial Contractions Burden; Mean (Standard Deviation); Unit of measure: log(Episodes/hour)
	Number Analyzed	29 participants	30 participants	59 participants
		1.26 (1.35)	1.04 (1.49)	1.15 (1.42)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Magnesium Supplement	Placebo
Arm/Group Description:	400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	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
Overall Number of Participants Analyzed	29	30
Mean (Standard Deviation); Unit of Measure: Episodes/hour
	-0.6 (7)	-5.6 (33)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oral Magnesium Supplement	Placebo
Arm/Group Description:	400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	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
Overall Number of Participants Analyzed	29	30
Mean (Standard Deviation); Unit of Measure: mEq/L
	0.07 (0.09)	0 (.1)

Adverse Events

Time Frame	59 days, from day 21 of the intervention to day 80
Adverse Event Reporting Description	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.
Arm/Group Title	Oral Magnesium Supplement	Placebo
Arm/Group Description	400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	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
All-Cause Mortality
	Oral Magnesium Supplement	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/29 (0.00%)	0/30 (0.00%)
Serious Adverse Events
	Oral Magnesium Supplement	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/29 (0.00%)	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Oral Magnesium Supplement	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	15/29 (51.72%)	2/30 (6.67%)
Gastrointestinal disorders
Gastrointestinal Symptoms *	15/29 (51.72%)	2/30 (6.67%)
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Pamela Lutsey, PhD MPH
• Organization: University of Minnesota
• Phone: 612-624-5812
• EMail: lutsey@umn.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: E1697. doi: 10.3390/nu12061697.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02837328
• Other Study ID Numbers: 1605M87323
• First Submitted: June 22, 2016
• First Posted: July 19, 2016
• Results First Submitted: February 1, 2019
• Results First Posted: April 30, 2019
• Last Update Posted: November 1, 2019