Status:
COMPLETED
Neuroprotective and Cardioprotective Effects Of Palm Vitamin E Tocotrienols
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
Malaysia Palm Oil Board
Conditions:
Cerebrovascular Disorders
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load o...
Detailed Description
Stroke is the third largest cause of death after heart disease and cancer in Malaysia. It is estimated that 52,000 Malaysians suffer stroke annually. In 2005, 3245 cases of stroke were fatal. It is pr...
Eligibility Criteria
Inclusion
- Participant able to understand and has signed and dated the Informed Consent Form
- Participant can be either a male or female
- Participant is more than 35 years of age
- Participant has total cholesterol between 5.2 - 6.2 mmol/L and LDL cholesterol between 2.6 - 4.2 mmol/L
- Participant is able to comply with visits and medications
- Participant has normal liver function (total protein, total albumin, total globulin, total bilirubin, SGOT and SGPT)
- Participants who satisfy the Inclusion and Exclusion Criteria for Study in General with one or more of the following conditions will be eligible for MRI screening:
- More than 40 years of age
- Stable hypertension requiring only out-patient management
- Diabetes mellitus requiring only out-patient management
- Ischaemic heart disease requiring only out-patient management
- Body mass index more than 25 (overweight or obese)
Exclusion
- Female participants who are pregnant
- Participant has previously received vitamin E supplementation (tocotrienols or tocopherols) within the past 3 months at the time of recruitment
- Participant has a history of cancer or has undergone radiation therapy
- Participant has a history of major organ dysfunction, such as moderate or severe hepatic impairment, severe renal insufficiency, severe or unstable cardiovascular, respiratory, hematological, endocrinological, neurological or other somatic disorders resulting in previous hospitalization.
- Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
- Participant is requiring long term anti-epileptics, hypnotics, and chronic medications for hypercholesterolemia
- Participant has very high cholesterol levels, total cholesterol above 6.2 mmol/L and LDL cholesterol above 4.2 mmol/L, which require medical treatment.
- Participant is requiring long term non-steroidal anti-inflammatory (NSAID) medication.
- Participant has a history of hypersensitivity to vitamin E.
- Participant has signs of alcohol and drug dependence or abuse.
- Participant is unable to understand and comply with the elements in the consent form.
- In addition, the participant must not have any contraindication to have MRI examinations including:
- Biostimulators (e.g. cardiac pacemaker and implanted spinal cord stimulator)
- Neurostimulators
- Aneurysm clips in the brain
- Cochlear implants
- Hearing aids
- Orthopaedic implants less than 2 months old
- Metal fragments in eyes Any further implants or foreign body not listed above should have the safety assessed by a radiologist prior to recruitment into the MRI study.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00753532
Start Date
November 1 2007
End Date
March 1 2012
Last Update
May 25 2022
Active Locations (1)
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1
Kepala Batas Hospital
Kepala Batas, Pulau Pinang, Malaysia, 13200