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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
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 28, 2019
    Last Updated
    July 28, 2020
    Sponsor
    University of British Columbia
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    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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