SO03-01 - EVALUATION OF THE EFFECT OF N-3 SUPPLEMENTATION ON FUNCTIONAL IMPROVEMENT IN POSTSTROKE PATIENTS - SO3-01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014730-22-IT

Enrollment

Registered

2009-09-10

Start date

2009-08-31

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Post ischemic stroke

Interventions

Trade Name: SEACOR Pharmaceutical Form: Capsule, soft INN or Proposed INN: Omega-3-triglycerides Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Principal inclusion criteria are: Patients of all ages; Patients of both sexes Patients malnourished and well-nourished Patients with previous ischemic stroke Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Principal exclusion criteria are: presence of other neurological diseases malignancies or progressive and degenerative diseases; severe liver disease; severe renal insufficiency. patients with score > 20 at mini mental test examination (for the exclusion of dementia) patients treated with antidepressants for less than a week

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to test the effectiveness of fatty acids of omega-3 series on functional improvement in poststroke subject assessed with specific scales;Secondary Objective: The secondary objectives are: a) to assess the effect on post stroke depression. b) to assess the improvement of lipemic pattern (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) before and after treatment c) to assess the effect on dysphagia and nutritional status;Primary end point(s): The main objective is to test the effectiveness of fatty acids of omega-3 series on functional improvement in poststroke subject assessed with specific scales	—

Measure

Time frame

Main Objective: The main objective is to test the effectiveness of fatty acids of omega-3 series on functional improvement in poststroke subject assessed with specific scales;Secondary Objective: The secondary objectives are: a) to assess the effect on post stroke depression. b) to assess the improvement of lipemic pattern (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) before and after treatment c) to assess the effect on dysphagia and nutritional status;Primary end point(s): The main objective is to test the effectiveness of fatty acids of omega-3 series on functional improvement in poststroke subject assessed with specific scales

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026