Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
Primary Purpose
Ventricular Premature Complexes, Atrial Premature Complexes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium glycinate
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Ventricular Premature Complexes focused on measuring athlete, premature ventricular contraction, premature atrial contraction, ectopic heartbeat, palpitation
Eligibility Criteria
Inclusion Criteria:
- Exercisers; defined as greater than 2.5 hours/week of at least moderate intensity exercise
- History of palpitations
- Average daily cumulative PVC/PAC count that is greater than 720 (measured with 48-hour Holter monitoring), AND/OR symptomatic from their PAC/PVCs
- Able to provide informed consent
- Able to participate in ongoing follow-up as required
- Able to swallow capsules
Exclusion Criteria:
- Current or regular use of an oral magnesium or calcium supplementation within the past year
- Current or regular use of a multivitamin or meal replacement product containing greater than 50mg of magnesium or 200mg of calcium within the past year
- Planning on becoming pregnant or currently pregnant or lactating
- Structural cardiac disease
- Documented atrial fibrillation
- Previous cardiac surgery including ablation for atrial fibrillation and/or ventricular arrhythmia
- Use of antiarrhythmic drugs, beta-blockers, calcium channel blockers, OR diuretics
- Hypomagnesemia (serum magnesium less than 0.7)
- Bilirubin (greater than or equal to 3mg/dL)
- Aspartate transaminase (AST) or alanine transaminase (ALT) greater than or equal to five times the upper limits of normal
- Glomerular filtration rate (GFR) less than 60
- Current or previous (within the four weeks prior to enrollment) use of any proton pump inhibitor (omeprazole, pantoprazole,), Gentamycin, Tobramycin, Amphotericin B, Ketoconazole, Mephalan, Eroposide, aminoglycosides or medication deemed by the PI as contraindicated)
- Alcohol intake greater than 15 standard drinks/week for men or greater than 10 standard drinks/week for women
- Illicit drug use
- Diabetes mellitus, kidney disease, irritable bowel disease or neuromuscular disease
- Diagnosis of cancer within the past five years (except basal/squamous cell limited to the skin)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo to magnesium
Magnesium to placebo
Arm Description
Participants will be asked to consume a daily placebo (cellulose) capsule for 12 weeks. They will then cross-over and consume 200mg of elemental magnesium in the form of magnesium glycinate daily for 12 weeks.
Participants will be asked to consume 200mg of elemental magnesium in the form of magnesium glycinate daily. They will then cross-over and consume a daily placebo (cellulose) capsule for 12 weeks.
Outcomes
Primary Outcome Measures
PAC burden total, magnesium intervention
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
PVC burden total, magnesium intervention
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Cardiac symptom burden, magnesium intervention
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
PAC burden total, placebo intervention
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
PVC burden total, placebo intervention
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Cardiac symptom burden, placebo intervention
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
Secondary Outcome Measures
Number of ectopic runs, magnesium intervention
Average number of ectopic runs (>3 beats) per day. Assessed with 48-hour Holter monitoring.
Number of sustained arrhythmias, magnesium intervention
Average number of sustained arrhythmias (>30 seconds) per day. Assessed with 48-hour Holter monitoring.
Subjective Quality of Life (questionnaire), magnesium intervention
The palpitation questionnaire is comprised of 12 questions (4 focused on the extent to which participants are bothered by symptoms associated with palpitations, 2 focused on the extent to which participants feel limited in their daily life due to palpitations, and 6 focused on the difficulty that participants feel in doing daily activities due to palpitations). Responses are given on a 7-point scale where 1 represents being not at all bothered, limited or experiencing no difficulty, and 7 represents being extremely bothered, limited or experiencing extreme difficulty.
Gastrointestinal symptom burden, magnesium intervention
Participants will be asked to report gastrointestinal symptoms every time they occur. This consists of the symptoms they are experiencing (i.e. nausea, bloating, heart burn, etc.) as well as symptom severity. Severity will be ranked between 1 and 5 where 1 means the symptoms were barely noticeable and did not affect daily life and, 5 means that the participant had to stop what they were doing to rest or that they had to alter their plans.
Subjective performance changes, magnesium intervention
Changes in physical performance will be assessed with a questionnaire inquiring about injuries, average intensity of exercise (ranked from 0 to 10, 0 being no activity at all and 10 being regular maximal effort training), perceived ability to recover after exercise bouts and typical volume (time, distance and load/weight).
Number of ectopic runs, placebo intervention
Average number of ectopic runs (>3 beats) per day. Assessed with 48-hour Holter monitoring.
Number of sustained arrhythmias, placebo intervention
Average number of sustained arrhythmias (>30 seconds) per day. Assessed with 48-hour Holter monitoring.
Subjective Quality of Life (questionnaire), placebo intervention
The palpitation questionnaire is comprised of 12 questions (4 focused on the extent to which participants are bothered by symptoms associated with palpitations, 2 focused on the extent to which participants feel limited in their daily life due to palpitations, and 6 focused on the difficulty that participants feel in doing daily activities due to palpitations). Responses are given on a 7-point scale where 1 represents being not at all bothered, limited or experiencing no difficulty, and 7 represents being extremely bothered, limited or experiencing extreme difficulty.
Gastrointestinal symptom burden, placebo intervention
Participants will be asked to report gastrointestinal symptoms every time they occur. This consists of the symptoms they are experiencing (i.e. nausea, bloating, heart burn, etc.) as well as symptom severity. Severity will be ranked between 1 and 5 where 1 means the symptoms were barely noticeable and did not affect daily life and, 5 means that the participant had to stop what they were doing to rest or that they had to alter their plans.
Subjective performance changes, placebo intervention
Changes in physical performance will be assessed with a questionnaire inquiring about injuries, average intensity of exercise (ranked from 0 to 10, 0 being no activity at all and 10 being regular maximal effort training), perceived ability to recover after exercise bouts and typical volume (time, distance and load/weight).
Full Information
NCT ID
NCT04186728
First Posted
November 28, 2019
Last Updated
July 28, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04186728
Brief Title
Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
Official Title
Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Magnesium is a mineral which is essential to many of the processes which happen in the body. This includes normal function of muscles; including the heart. Studies have shown that oral magnesium supplementation can help reduce the frequency of extra heart beats (premature ventricular contractions (PVC) and premature atrial contractions (PAC)) while also reducing the severity of their associated symptoms. Oral magnesium supplementation has yet to be investigated in athletes with lots of PVCs and/or PACs.
Most of the magnesium in your body is stored in the bones. Your body may take magnesium from your bones to maintain magnesium levels in your blood. This makes it possible for people to have low levels of magnesium in their body but normal levels in their blood. Over time, this process can decrease the total amount in your body and impact other body functions. Magnesium is also lost in sweat making athletes more vulnerable to having low levels in their body.
Magnesium is particularly important in the function of the myocardium (heart muscle fibers). It has been proposed that the PVCs and PACs experienced by some people are a result of low levels of total body magnesium. Current drug treatments to control PVCs and PACs include medications such as beta blockers. These treatments are not without their side effects. Generally, these medications are only effective if individuals do not have a structural heart disease. These drugs may also decrease your ability to exercise and are banned by some governing bodies in sport.
The hypotheses of this study are:
Oral magnesium supplementation reduces the frequency of PVCs and/or PACs.
Oral magnesium supplementation reduces the symptoms associated with PVCs and PACs.
To be eligible for the study, individuals will be required to have a certain number of PVCs and PACs in a day. This study will involve two groups of participants. A total of 25 participants will be recruited for each group resulting in 50 participants in the study. During the study, one group will take a daily magnesium capsule for 12 weeks before switching to a placebo for 12 weeks. The other group will have the placebo intervention before switching to magnesium. Participants will be randomized into one of the two groups and will remain blinded until their participation in the study ends. The research team will also be unaware of each participant's current intervention however, this information will be available in case of medical emergency.
Participants will be asked to attend one screening visit and three study visits. During these visits, a blood sample will be taken and you will be asked to complete questionnaires about you physical fitness and quality of life. You will also be asked to wear a Holter monitor for 48 hours in order to count the number of PVCs and PACs you have daily. In addition to these assessments, you will also complete an exercise stress test during your screening visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Premature Complexes, Atrial Premature Complexes
Keywords
athlete, premature ventricular contraction, premature atrial contraction, ectopic heartbeat, palpitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized double blinded placebo controlled experiment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo to magnesium
Arm Type
Placebo Comparator
Arm Description
Participants will be asked to consume a daily placebo (cellulose) capsule for 12 weeks. They will then cross-over and consume 200mg of elemental magnesium in the form of magnesium glycinate daily for 12 weeks.
Arm Title
Magnesium to placebo
Arm Type
Experimental
Arm Description
Participants will be asked to consume 200mg of elemental magnesium in the form of magnesium glycinate daily. They will then cross-over and consume a daily placebo (cellulose) capsule for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium glycinate
Intervention Description
Daily magnesium capsule.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily placebo capsule.
Primary Outcome Measure Information:
Title
PAC burden total, magnesium intervention
Description
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
Time Frame
Change in PAC burden after 12 weeks of magnesium intervention
Title
PVC burden total, magnesium intervention
Description
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Time Frame
Change in PVC burden after 12 weeks of magnesium intervention
Title
Cardiac symptom burden, magnesium intervention
Description
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
Time Frame
Change in cardiac symptom burden after 12 weeks of magnesium intervention
Title
PAC burden total, placebo intervention
Description
Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.
Time Frame
Change in PAC burden after 12 weeks of placebo intervention
Title
PVC burden total, placebo intervention
Description
Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.
Time Frame
Change in PVC burden after 12 weeks of placebo intervention
Title
Cardiac symptom burden, placebo intervention
Description
The number of patient reported symptoms that correspond with documented PVCs or PACs (some participants may be experiencing palpitations but may not actually be symptomatic).
Time Frame
Change in cardiac symptom burden after 12 weeks of placebo intervention
Secondary Outcome Measure Information:
Title
Number of ectopic runs, magnesium intervention
Description
Average number of ectopic runs (>3 beats) per day. Assessed with 48-hour Holter monitoring.
Time Frame
Change in number of ectopic runs after 12 weeks of magnesium intervention
Title
Number of sustained arrhythmias, magnesium intervention
Description
Average number of sustained arrhythmias (>30 seconds) per day. Assessed with 48-hour Holter monitoring.
Time Frame
Change in number of sustained arrhythmias after 12 weeks of magnesium intervention
Title
Subjective Quality of Life (questionnaire), magnesium intervention
Description
The palpitation questionnaire is comprised of 12 questions (4 focused on the extent to which participants are bothered by symptoms associated with palpitations, 2 focused on the extent to which participants feel limited in their daily life due to palpitations, and 6 focused on the difficulty that participants feel in doing daily activities due to palpitations). Responses are given on a 7-point scale where 1 represents being not at all bothered, limited or experiencing no difficulty, and 7 represents being extremely bothered, limited or experiencing extreme difficulty.
Time Frame
Change in subjective quality of life after 12 weeks of magnesium intervention
Title
Gastrointestinal symptom burden, magnesium intervention
Description
Participants will be asked to report gastrointestinal symptoms every time they occur. This consists of the symptoms they are experiencing (i.e. nausea, bloating, heart burn, etc.) as well as symptom severity. Severity will be ranked between 1 and 5 where 1 means the symptoms were barely noticeable and did not affect daily life and, 5 means that the participant had to stop what they were doing to rest or that they had to alter their plans.
Time Frame
Number of Gastrointestinal symptoms over 12 weeks of magnesium intervention
Title
Subjective performance changes, magnesium intervention
Description
Changes in physical performance will be assessed with a questionnaire inquiring about injuries, average intensity of exercise (ranked from 0 to 10, 0 being no activity at all and 10 being regular maximal effort training), perceived ability to recover after exercise bouts and typical volume (time, distance and load/weight).
Time Frame
Change in subjective physical performance after 12 weeks of magnesium intervention
Title
Number of ectopic runs, placebo intervention
Description
Average number of ectopic runs (>3 beats) per day. Assessed with 48-hour Holter monitoring.
Time Frame
Change in number of ectopic runs after 12 weeks of placebo intervention
Title
Number of sustained arrhythmias, placebo intervention
Description
Average number of sustained arrhythmias (>30 seconds) per day. Assessed with 48-hour Holter monitoring.
Time Frame
Change in number of sustained arrhythmias after 12 weeks of placebo intervention
Title
Subjective Quality of Life (questionnaire), placebo intervention
Description
The palpitation questionnaire is comprised of 12 questions (4 focused on the extent to which participants are bothered by symptoms associated with palpitations, 2 focused on the extent to which participants feel limited in their daily life due to palpitations, and 6 focused on the difficulty that participants feel in doing daily activities due to palpitations). Responses are given on a 7-point scale where 1 represents being not at all bothered, limited or experiencing no difficulty, and 7 represents being extremely bothered, limited or experiencing extreme difficulty.
Time Frame
Change in subjective quality of life after 12 weeks of placebo intervention
Title
Gastrointestinal symptom burden, placebo intervention
Description
Participants will be asked to report gastrointestinal symptoms every time they occur. This consists of the symptoms they are experiencing (i.e. nausea, bloating, heart burn, etc.) as well as symptom severity. Severity will be ranked between 1 and 5 where 1 means the symptoms were barely noticeable and did not affect daily life and, 5 means that the participant had to stop what they were doing to rest or that they had to alter their plans.
Time Frame
Number of Gastrointestinal symptoms over 12 weeks of the placebo intervention.
Title
Subjective performance changes, placebo intervention
Description
Changes in physical performance will be assessed with a questionnaire inquiring about injuries, average intensity of exercise (ranked from 0 to 10, 0 being no activity at all and 10 being regular maximal effort training), perceived ability to recover after exercise bouts and typical volume (time, distance and load/weight).
Time Frame
Change in subjective physical performance after 12 weeks of the placebo intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Exercisers; defined as greater than 2.5 hours/week of at least moderate intensity exercise
History of palpitations
Average daily cumulative PVC/PAC count that is greater than 720 (measured with 48-hour Holter monitoring), AND/OR symptomatic from their PAC/PVCs
Able to provide informed consent
Able to participate in ongoing follow-up as required
Able to swallow capsules
Exclusion Criteria:
Current or regular use of an oral magnesium or calcium supplementation within the past year
Current or regular use of a multivitamin or meal replacement product containing greater than 50mg of magnesium or 200mg of calcium within the past year
Planning on becoming pregnant or currently pregnant or lactating
Structural cardiac disease
Documented atrial fibrillation
Previous cardiac surgery including ablation for atrial fibrillation and/or ventricular arrhythmia
Use of antiarrhythmic drugs, beta-blockers, calcium channel blockers, OR diuretics
Hypomagnesemia (serum magnesium less than 0.7)
Bilirubin (greater than or equal to 3mg/dL)
Aspartate transaminase (AST) or alanine transaminase (ALT) greater than or equal to five times the upper limits of normal
Glomerular filtration rate (GFR) less than 60
Current or previous (within the four weeks prior to enrollment) use of any proton pump inhibitor (omeprazole, pantoprazole,), Gentamycin, Tobramycin, Amphotericin B, Ketoconazole, Mephalan, Eroposide, aminoglycosides or medication deemed by the PI as contraindicated)
Alcohol intake greater than 15 standard drinks/week for men or greater than 10 standard drinks/week for women
Illicit drug use
Diabetes mellitus, kidney disease, irritable bowel disease or neuromuscular disease
Diagnosis of cancer within the past five years (except basal/squamous cell limited to the skin)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Tran, MSc
Phone
604-822-9494
Email
raymond.tran@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Mate, BA
Phone
604-822-9494
Email
rebecca.mate@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James McKinney, MD, FRCP, MSc
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no current plans to share data with other researchers. This will only be reconsidered if the journal that the manuscript is submitted to requests that the study data be made public.
Learn more about this trial
Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.
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