Randomised controlled trial (RCT) of dietary intervention to sustain sinus rhythm in patients following initiation of treatment for atrial fibrillation or flutter

ISRCTN	ISRCTN16448451
DOI	https://doi.org/10.1186/ISRCTN16448451
Secondary identifying numbers	RHC11281

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Peter Elton
Scientific

Wigan & Bolton Health Authority
Bryan House
61 Standishgate
Wigan
WN1 1AH
United Kingdom

Phone	+44 (0)1942 772711
Email	peter.elton@wab-ha.nwest.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised controlled trial (RCT) of dietary intervention to sustain sinus rhythm in patients following initiation of treatment for atrial fibrillation or flutter
Study objectives	Effectiveness of policy of providing dietary instruction to eat oil rich fish to maintain sinus rhythm. To increase sustained sinus rhythm following cardioconversion in patients to be cardioverted for atrial fibrillation or flutter.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Atrial fibrillation and flutter
Intervention	1. Addition of fish oil to the diet 2. Maintenance of normal diet
Intervention type	Other
Primary outcome measure	The primary outcome measure will be the number of patients in sustained sinus rhythm for a period of 12 months.
Secondary outcome measures	1. Mortality associated with coronary heart disease 2. All mortality 3. Coronary heart disease related morbidity & number of strokes 4. Quality of life assessment 5. Suitability of dietary instructions 6. The patients perception of any change in weekly shopping bills 7. An economic analysis through consultation with a Health Economist.
Overall study start date	01/07/1998
Completion date	01/07/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Inpatients and outpatients aged 18 years and above, recently diagnosed as having atrial fibrillation or flutter, as determined by electrocardiogram (ECG).
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/07/1998
Date of final enrolment	01/07/2002

Wigan & Bolton Health Authority

Wigan
WN1 1AH
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive North West (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/01/2005		Yes	No

26/10/2018: No publications found, verifying study status with principal investigator.