Premature Atrial ContractionPhase 2NCT02837328
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
A Phase 2 study testing Oral Magnesium Supplement in people with Premature Atrial Contraction, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Atrial Contraction
- What is being tested?
- Oral Magnesium Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 15 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55 and older
- Ability to speak English
- Availability to attend baseline and follow-up visit approximately 12 weeks after baseline
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - Twin Cities
Minneapolis, Minnesota, 55454
About this study
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).
Read the detailed description
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.
- Conditions
- Premature Atrial Contraction
- Being tested
- Oral Magnesium Supplement, Placebo
- Keywords
- Magnesium Supplementation, Magnesium, Dietary Supplement, Arrhythmia
- Medical subject headings
- Atrial Premature Complexes, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Magnesium SupplementDrug
400 mg Magnesium Citrate 1x daily for 12 weeks
PlaceboDrug
Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral Magnesium Supplement | Experimental | 400 mg Magnesium Citrate 1x daily for 12 weeks Receives: Drug: Oral Magnesium Supplement |
| Placebo | Placebo comparator | Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Premature Atrial Contractions (PACs)
The primary endpoint will be the change in burden of PACs
Measured: Change from Baseline at 10 weeks
Secondary outcomes (1)
Change in Magnesium Concentration
The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.
Measured: Baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start1 Mar 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Atrial ContractionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela L Lutsey, PhD, Principal investigator, University of MinnesotaAlvaro Alonso, MD PhD, Principal investigator, University of MinnesotaLin Y Chen, MD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837328
- Sponsor's protocol ID
- 1605M87323
- Status last verified
- Oct 2019
- First submitted
- 22 Jun 2016
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32517192
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT02837328
- Acronym / sponsor ID
- 1605M87323
- Conditions
- Premature Atrial Contraction
- Keywords
- Magnesium Supplementation, Magnesium, Dietary Supplement, Arrhythmia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Posted 30 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Magnesium Supplement | Experimental | Drug: Oral Magnesium Supplement400 mg Magnesium Citrate 1x daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55 and older
- Ability to speak English
- Availability to attend baseline and follow-up visit approximately 12 weeks after baseline
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Magnesium Supplement400 mg Magnesium Citrate 1x daily for 12 weeks | Drug | Oral Magnesium Supplement |
| PlaceboPlacebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks | Drug | Placebo |
Primary outcome
Change in Premature Atrial Contractions (PACs)
Time frame: Change from Baseline at 10 weeks
The primary endpoint will be the change in burden of PACs
1 secondary outcome
Change in Magnesium Concentration
Time frame: Baseline and week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32517192Alonso 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela L Lutsey, PhD principal investigator
University of Minnesota
Alvaro Alonso, MD PhD principal investigator
University of Minnesota
Lin Y Chen, MD study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Magnesium Supplement in people with Premature Atrial Contraction, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Premature Atrial Contractions (PACs) (time frame: Change from Baseline at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.