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Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

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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:
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
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
Hide 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
Arm/Group Title Oral Magnesium Supplement Placebo Total
Hide 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
Hide 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)
1.Primary Outcome
Title Change in Premature Atrial Contractions (PACs)
Hide Description The primary endpoint will be the change in burden of PACs
Time Frame Change from Baseline at 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Magnesium Supplement Placebo
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Magnesium Supplement Placebo
Hide 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)
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
Hide 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%) 
Hide Serious Adverse Events
Oral Magnesium Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%) 
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Pamela Lutsey, PhD MPH
Organization: University of Minnesota
Phone: 612-624-5812
EMail: lutsey@umn.edu
Layout table for additonal information
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