Fish Oils (Omega 3) in ischaemic stroke

A Randomised, Placebo-Controlled Intervention Trial of Omega-3 PUFA, (Fish Oils), in People with Ischaemic Stroke

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000207617

Acronym

FOILS

Enrollment

220

Registered

2005-08-25

Start date

2004-06-01

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

Interventions

Participants receive 3 gm of fish oil (containing omega-3 PUFAs) orally for the treatment group Participants are seen at 0 and 12 weeks for clinical assessments, anthropometry, venepuncture for haematological and biochemical analyses, assessment of compliance and the recording of adverse events. In addition, a telephone follow-up visit will be performed at 6 and 11 weeks to ascertain safety data (SAEs) and compliance to study treatment.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

1. CT confirmed first-ever or recurrent ischaemic stroke 2. Clinically stable with atheromatous disease history greater than 3 months.

Exclusion criteria

1. Known intolerance or hypersensitivity to fish and /or fish oils. 2. Current use of fish oils (dietary supplements) 3. Known to be pregnant or breast feeding 4. Active disease causing malabsorption.

Outcome results