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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00232245




Registration number
NCT00232245
Ethics application status
Date submitted
2/10/2005
Date registered
4/10/2005
Date last updated
30/05/2013

Titles & IDs
Public title
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
Scientific title
Secondary ID [1] 0 0
2003.216
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Fish oil - Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio

No intervention: Control - No fish oil exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Atrial tachycardia and atrial fibrillation burden
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Frequency and duration of atrial tachycardia/fibrillation episodes
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
* Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.
Minimum age
18 Years
Maximum age
88 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patients with chronic atrial fibrillation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sparks
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00232245