A randomised double-blind, placebo-controlled trial of magnesium in patients with paroxysmal lone atrial fibrillation.

In patients with paroxysmal lone atrial fibrillation can oral magnesium compared to placebo reduce the incidence of atrial fibrillation?

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000181000

Enrollment

200

Registered

2010-03-01

Start date

2010-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a double-blind, placebo-controlled trial of oral magnesium in patients suffering from paroxysmal atrial fibrillation. The aim of this study is to investigate the effect of oral magnesium on the incidence of paroxysmal lone atrial fibrillation. In order to do this participants will be randomised to oral magnesium or placebo. The participants’ incidence of atrial fibrillation will be monitored for a 12 month period to determine whether oral magnesium reduces the number of episodes of atrial fibrillation.

Interventions

One oral tablet of Herron Magnesium Plus taken twice daily for 1 year following randomisation. Herron Magnesium Plus contains: Magnesium Oxide (Magnesium 320mg) 530.7mg Manganese sulfate monohydrate (Manganese 5mg) 15.4mg Pyridoxine hydrochloride (vitamin B6) 50mg

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with paroxysmal lone atrial fibrillation documented by an electrical tracing (minimum of 2 episodes within prior 12 months)

Exclusion criteria

1.Renal Failure with a serum urea > 10 mmol/L. 2.Untreated hyperthyroidism. 3.Atrial fibrillation with associated cardiac disease with an abnormal transthoracic echocardiogram; e.g. cardiomyopathy, enlarged left atrium, valvular heart disease. 4.Symptomatic Inflammatory Bowel disease. 5.Currently taking Magnesium supplementation. 6.Daily consumption of alcohol >4 standard drinks. 7.Transient paroxysmal atrial fibrillation secondary to other reversible disorders (e.g., thyrotoxicosis, cardiac or thoracic surgery, pneumonia, severe anemia)

Outcome results