Oral Magnesium Supplementation in Athletes With Premature Ventricular Contractions or Premature Atrial Contractions.

NCT04186728 | Unknown

• 1 other identifier: H19-01142
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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:

1. 1.Oral magnesium supplementation reduces the frequency of PVCs and/or PACs.
2. 2.Oral magnesium supplementation reduces the symptoms associated with PVCs and PACs.

Conditions

Ventricular Premature Complexes; Atrial Premature Complexes

Keywords

athlete; premature ventricular contraction; premature atrial contraction; ectopic heartbeat; palpitation

Outcome Measures

Primary Outcomes (6)

• PAC burden total, magnesium intervention

  Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.

  Change in PAC burden after 12 weeks of magnesium intervention

• PVC burden total, magnesium intervention

  Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.

  Change in PVC burden after 12 weeks of magnesium intervention

• 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).

  Change in cardiac symptom burden after 12 weeks of magnesium intervention

• PAC burden total, placebo intervention

  Average number of premature atrial contractions in a hour. Assessed with 48-hour Holter monitoring.

  Change in PAC burden after 12 weeks of placebo intervention

• PVC burden total, placebo intervention

  Average number of premature ventricular contractions in a hour. Assessed with 48-hour Holter monitoring.

  Change in PVC burden after 12 weeks of placebo intervention

• 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).

  Change in cardiac symptom burden after 12 weeks of placebo intervention

Secondary Outcomes (10)

• Number of ectopic runs, magnesium intervention

  Change in number of ectopic runs after 12 weeks of magnesium intervention

• Number of sustained arrhythmias, magnesium intervention

  Change in number of sustained arrhythmias after 12 weeks of magnesium intervention

• Subjective Quality of Life (questionnaire), magnesium intervention

  Change in subjective quality of life after 12 weeks of magnesium intervention

• Gastrointestinal symptom burden, magnesium intervention

  Number of Gastrointestinal symptoms over 12 weeks of magnesium intervention

• Subjective performance changes, magnesium intervention

  Change in subjective physical performance after 12 weeks of magnesium intervention

Study Arms (2)

Placebo to magnesium

PLACEBO COMPARATOR

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.

Dietary Supplement: Magnesium glycinate; Other: Placebo

Magnesium to placebo

EXPERIMENTAL

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.

Dietary Supplement: Magnesium glycinate; Other: Placebo

Interventions

Magnesium glycinate DIETARY_SUPPLEMENT

Daily magnesium capsule.

Magnesium to placebo; Placebo to magnesium

Placebo OTHER

Daily placebo capsule.

Magnesium to placebo; Placebo to magnesium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Ventricular Premature Complexes; Atrial Premature Complexes; Cardiac Complexes, Premature

Interventions

magnesium diglycinate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James McKinney, MD, FRCP, MSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tran, MSc

CONTACT

604-822-9494; raymond.tran@vch.ca

Rebecca Mate, BA

CONTACT

604-822-9494; rebecca.mate@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized double blinded placebo controlled experiment

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 5, 2019
• Study Start: September 30, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share