Trial Outcomes & Findings for Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias (NCT NCT02837328)

NCT ID: NCT02837328

Last Updated: 2019-11-01

Results Overview

The primary endpoint will be the change in burden of PACs

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: Change from Baseline at 10 weeks
• Results posted on: 2019-11-01

Participant Flow

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.

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).

Participant milestones

Measure	Oral Magnesium Supplement 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	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
Overall Study STARTED	29	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

Baseline characteristics by cohort

Measure	Oral Magnesium Supplement n=29 Participants 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	Placebo n=30 Participants 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 n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 5.3 • n=5 Participants	61.6 years STANDARD_DEVIATION 5.2 • n=7 Participants	61.5 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	30 participants n=7 Participants	59 participants n=5 Participants
Serum Magnesium Concentrations	1.74 mEq/L STANDARD_DEVIATION 0.12 • n=5 Participants	1.71 mEq/L STANDARD_DEVIATION .1 • n=7 Participants	1.72 mEq/L STANDARD_DEVIATION 0.11 • n=5 Participants
Premature Arterial Contractions Burden	8.5 episode/hour STANDARD_DEVIATION 14 • n=5 Participants	20.2 episode/hour STANDARD_DEVIATION 80 • n=7 Participants	14.5 episode/hour STANDARD_DEVIATION 58 • n=5 Participants
Log Premature Arterial Contractions Burden	1.26 log(Episodes/hour) STANDARD_DEVIATION 1.35 • n=5 Participants	1.04 log(Episodes/hour) STANDARD_DEVIATION 1.49 • n=7 Participants	1.15 log(Episodes/hour) STANDARD_DEVIATION 1.42 • n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline at 10 weeks

The primary endpoint will be the change in burden of PACs

Outcome measures

Measure	Oral Magnesium Supplement n=29 Participants 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	Placebo n=30 Participants 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
Change in Premature Atrial Contractions (PACs)	-0.6 Episodes/hour Standard Deviation 7	-5.6 Episodes/hour Standard Deviation 33

SECONDARY outcome

Timeframe: Baseline and week 10

The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.

Outcome measures

Measure	Oral Magnesium Supplement n=29 Participants 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	Placebo n=30 Participants 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
Change in Magnesium Concentration	0.07 mEq/L Standard Deviation 0.09	0 mEq/L Standard Deviation .1

Adverse Events

Oral Magnesium Supplement

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Magnesium Supplement n=29 participants at risk 400 mg Magnesium Citrate 1x daily for 12 weeks Oral Magnesium Supplement: 400 mg Magnesium Citrate 1x daily for 12 weeks	Placebo n=30 participants at risk 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
Gastrointestinal disorders Gastrointestinal Symptoms	51.7% 15/29 • 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.	6.7% 2/30 • 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.

Additional Information

Pamela Lutsey, PhD MPH

University of Minnesota

Phone: 612-624-5812

Email: lutsey@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place