ClinicalTrials.gov
ClinicalTrials.gov Menu

Stroke and Tocotrienol: Unique Role in Neuroprotection (SATURN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02263924
Recruitment Status : Recruiting
First Posted : October 13, 2014
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Clinical Research Centre Hospital Taiping
University of Science Malaysia
Information provided by (Responsible Party):
Seberang Jaya Clinical Research Centre

Brief Summary:

Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in patients with moderate ischemic stroke.

150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol 200mg twice a day for 6 months. Patients will be followed up and assessed on their functional recovery.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Dietary Supplement: Tocotrienol Dietary Supplement: Placebo capsules Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III, Single Centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Oral Vitamin E (Mixed Tocotrienol) for 6 Months in Patients With Moderate Acute Ischemic Stroke
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arm Intervention/treatment
Experimental: Experimental: Tocotrienol
Mixed tocotrienol 200mg twice a day for 6 months
Dietary Supplement: Tocotrienol
Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months

Placebo Comparator: Placebo (for tocotrienol)
Placebo capsules, 1 capsule twice a day for 6 months
Dietary Supplement: Placebo capsules
Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months




Primary Outcome Measures :
  1. Modified Rankin Score [ Time Frame: 6th Month ]
    Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)


Secondary Outcome Measures :
  1. Modified Rankin Score [ Time Frame: 3rd month ]
    Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)

  2. Modified Barthel Index [ Time Frame: 6th months ]
    • Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)

  3. NIHSS [ Time Frame: before dosing and at 6th month ]
    Reduction in NIHSS at the end of 6 months of treatment from baseline

  4. Composite score (MRS, NIHSS, mBI) [ Time Frame: 6th month ]
    Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95

  5. Modified Rankin Score [ Time Frame: 3rd month ]
    Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment

  6. Modified Rankin Score [ Time Frame: 6th month ]
    Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment

  7. MRI - Brain lesion volume [ Time Frame: 6th month ]
    Change in stroke lesion volume

  8. SF-36 [ Time Frame: 6th month ]
    quality of life

  9. CLOX and TMT Parts A & B [ Time Frame: 6th month ]
    Improvement in the score of CLOX and TMT Parts A & B at the end of 24-weeks of treatment from baseline

  10. Adverse event monitoring [ Time Frame: 6 months ]
    Adverse event outcomes in both groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20)

Inclusion Criteria:

  1. Age 35 years old and above.
  2. Subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischaemic stroke with NIHSS between 6 - 20.
  3. Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions.
  4. Subject has a modified Rankin Scale from 2-4.
  5. Subject has a clinical stroke diagnosis according to WHO stroke diagnosis.
  6. Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist
  7. Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

  1. Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
  2. Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event.
  3. Severe stroke as assessed clinically and/or by appropriate imaging techniques
  4. Subject has other significant non-ischemic brain lesion(s) which could affect function or disability.
  5. Time of ischemic stroke onset not exactly known
  6. Subject has documented underlying medical conditions which may affect assessment or follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart disease, severe liver disease or renal failure (based on recent medical history)
  7. Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia
  8. Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin)
  9. Any condition that in the judgment of the investigator would place the patient under undue risk
  10. Traumatic brain injury within the previous 30 days.
  11. Symptoms which are rapidly improving (as in transient ischemic stroke)
  12. The patient is pregnant, breast feeding or female of childbearing potential (unless the subject is willing to practice on double contraception measures for the study duration) until up to 1 month (30 days) after last treatment dose.
  13. Patients who have been included in any other clinical trial within the previous three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263924


Contacts
Contact: IRENE LOOI irenelooi@yahoo.com
Contact: WEN YAO MAK makwenyao@gmail.com

Locations
Malaysia
Seberang Jaya Clinical Research Centre Recruiting
Seberang Jaya, Pulau Pinang, Malaysia, 13700
Contact: IRENE LOOI       irenelooi@yahoo.com   
Contact: AWATIF RUSLI       awatif90rusli@gmail.com   
Principal Investigator: Irene Looi         
Sponsors and Collaborators
Seberang Jaya Clinical Research Centre
Clinical Research Centre Hospital Taiping
University of Science Malaysia
Investigators
Principal Investigator: IRENE LOOI SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
Study Director: KAH HAY YUEN University of Science Malaysia

Responsible Party: Seberang Jaya Clinical Research Centre
ClinicalTrials.gov Identifier: NCT02263924     History of Changes
Other Study ID Numbers: 2013-CRC-001-03
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances