Omega 3 and Ischemic Stroke; Fish Oil as an Option

NCT04386525 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 002518
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this trial, The investigators are going to investigate the improvement of neurological functions and infarced area of the brain in ischemic stroke patients after ingestion of omega 3 products that have high concentrations of DHA and EPA in comparison to control group. The study will assess the improvement by computerized calculation of the size of the infarcted area before and after the intervention and neurological assessment tools. The researchers will follow the scientific and ethical regulations prevent any harmful effect on recruited subjects.

Conditions

Ischemic Stroke; Neurological Injury; Stroke, Acute; Inflammatory Response; Permanent Injury; Neurologic Dysfunction; Neurological Disorder; Brain Ischemia; Brain Injuries

Keywords

Brain; Neurogenesis; Omega-3; DHA fatty acids; EPA fatty acids; Stroke; Fish Oil; trial

Outcome Measures

Primary Outcomes (3)

• Brain Infarction size

  will be assessed by square centimetres on MRI scan

  after 3 months of intervention

• Improvement of neurological symptoms and functions (Severity)

  Assessed by National Institutes of Health Stroke Scale. The scale range is from 0 to 42 as following: * 0 No stroke symptoms * 1-4 Minor stroke * 5-15 Moderate stroke * 16-20 Moderate to severe stroke * 21-42 Severe stroke

  after 3 months of intervention

• Improvement of neurological symptoms and functions (Dependence)

  Assessed by the modified Rankin Scale. The scale consists of degrees from 0 to 6 as following: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability 3. \- Moderate disability. 4. \- Moderately severe disability 5. \- Severe disability 6. \- Dead.

  after 3 months of intervention

Study Arms (2)

Omega-3

EXPERIMENTAL

Fish oil will be administered to this group. We will administer 4g per day of fish oil in three times with meals for one month with monitoring the health status regularly

Dietary Supplement: Omega-3 fish oil

Controle

NO INTERVENTION

for comparison with interventional arm

Interventions

Omega-3 fish oil DIETARY_SUPPLEMENT

soft gels,1000gm, 84% of DHA and EPA

Omega-3

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted ischemic occlusive stroke after successful reperfusion therapy - Stabilized in ICU or the inward
• Attack started 48 hours or less
• Can be fed by nasogastric tube or by himself
• MRI imaging was taken in the first 24 hours and CT \[10\]

You may not qualify if:

• Hemorrhagic stroke
• Non-occlusive hypoxic brain
• Global cerebral ischemia
• Transient ischemic attack
• Non-scanned by MRI or CT in the first 48 hours of onset
• Non-reperfused stroke patient or non-successful reperfusion therapy
• Deteriorating cases and not stabilised patients
• Attack exceeded 48 hours since onset
• Non-tolerated patients to feeding (NPO)
• Unstable source of thrombi (e.g. vegetation heart valves, unstable carotid atherosclerosis..etc)
• Presence of any coagulopathy
• Sickle cell anaemia
• Risk for shock ( e.g. septic shock, hypovolemic shock, cardiogenic shock...etc) - Time of onset is not reliably known
• Suspected non-stroke diagnosis
• Significant concurrent medical condition

Sponsors & Collaborators

• King Fahad Medical City: lead

MeSH Terms

Conditions

Ischemic Stroke; Trauma, Nervous System; Stroke; Neurologic Manifestations; Nervous System Diseases; Brain Ischemia; Brain Injuries

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma

Intervention Hierarchy (Ancestors)

Oils; Lipids

Central Study Contacts

Nauf Almansour, Stroke Consultant

CONTACT

+96653 941 7892; nalmansour.stroke@gmail.com

Wesam Alkassas, MBBS

CONTACT

+966538975400; wesam.alkassas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subspecialty Consultant Neurologist And Stroke Specialist

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: February 1, 2022
• Last Updated: May 14, 2020

Record last verified: 2020-05