Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000181000
Ethics application status
Approved
Date submitted
17/06/2009
Date registered
1/03/2010
Date last updated
1/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised double-blind, placebo-controlled trial of magnesium in patients with paroxysmal lone atrial fibrillation.
Scientific title
In patients with paroxysmal lone atrial fibrillation can oral magnesium compared to placebo reduce the incidence of atrial fibrillation?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paroxysmal lone atrial fibrillation 237047 0
Condition category
Condition code
Cardiovascular 237366 237366 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 236770 0
Prevention
Comparator / control treatment
One placebo oral tablet taken twice daily for 1 year following randomisation.
The placebo contains:
Calcium Hydrogen Phosphate
Pyridoxine Hydrogen Chloride
Cellulose microcrystalline
Calcium Stearate
Water
Opadry II white
Iron Oxide black
Carnauba wax
Control group
Placebo

Outcomes
Primary outcome [1] 238172 0
Incidence of atrial fibrillation confirmed by electrocardiogram or Holter monitor.
Timepoint [1] 238172 0
1 year following randomisation.
Primary outcome [2] 253431 0
Incidence of symptomatic atrial fibrillation detected by the patient, where an ECG was not possible.
Timepoint [2] 253431 0
1 year following randomisation.
Secondary outcome [1] 242462 0
nil
Timepoint [1] 242462 0
nil

Eligibility
Key inclusion criteria
Patients with paroxysmal lone atrial fibrillation documented by an electrical tracing (minimum of 2 episodes within prior 12 months)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent researcher will perform computer randomisation of participants The randomisation lists of ‘active’ and ‘placebo’ status will then be directly emailed to the hospital’s clinical trials pharmacist who will be responsible for all dispensing of study medication throughout the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e. computerised sequence generation using the statistical software MinitabTrademark(version 15)).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237168 0
Hospital
Name [1] 237168 0
Neuroscience Department, Barwon Health
Country [1] 237168 0
Australia
Primary sponsor type
Hospital
Name
Neuroscience Department, Barwon Health
Address
Ryrie Street
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 4657 0
None
Name [1] 4657 0
Address [1] 4657 0
Country [1] 4657 0
Other collaborator category [1] 709 0
Commercial sector/Industry
Name [1] 709 0
Sigma Pharmaceutical (Australia) Pty Ltd
Address [1] 709 0
96 Merrindale Drive,
Croydon, VIC 3136
Country [1] 709 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239260 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 239260 0
Barwon Health, The Geelong Hospital
Ryrie Street
Geelong VIC 3220
Ethics committee country [1] 239260 0
Australia
Date submitted for ethics approval [1] 239260 0
14/07/2009
Approval date [1] 239260 0
18/08/2009
Ethics approval number [1] 239260 0
09/22

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29755 0
Address 29755 0
Country 29755 0
Phone 29755 0
Fax 29755 0
Email 29755 0
Contact person for public queries
Name 13002 0
Associate Professor Peter Gates
Address 13002 0
Neuroscience Department
Barwon Health
Ryrie Street
Geelong VIC 3220
Country 13002 0
Australia
Phone 13002 0
+61 3 52267950
Fax 13002 0
+61 3 52267375
Email 13002 0
[email protected]
Contact person for scientific queries
Name 3930 0
Associate Professor Peter Gates
Address 3930 0
Neuroscience Department
Barwon Health
Ryrie Street
Geelong VIC 3220
Country 3930 0
Australia
Phone 3930 0
+61 3 52267950
Fax 3930 0
+61 3 52267375
Email 3930 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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