Sponsor study identifier
interventional
241
1 country
1
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)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 on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 15, 2008
Actual (reported)September 16, 2008
Actual (reported)March 2012
Actual (reported)March 2012
Actual (reported)Regression of white matter lesion load in terms of numbers and size in the brain
1 to 2 years
Regression of the carotid artery stenoses in terms of percentage
1 to 2 years
The improvement in the lipid profile other markers associated with increased cardiovascular risk
1 to 2 years
Improvement in liver echogenicity.
1 to 2 years
121 volunteers in MRI(+ve) cohort were randomized into two groups to receive either 200mg palm vitamin E (tocotrienols) softgel capsules or a identical looking placebo twice daily. 62 volunteers received 200mg palm vitamin E (tocotrienols) and the remaining 59 received placebo. They were followed up every 3 months for a period of 2 years for their blood biochemistry profile and MRI of the brain was conducted at baseline, 12 months and 24 months..
120 volunteers in MRI(-ve) cohort were randomized into two groups to receive either 200mg palm vitamin E (tocotrienols) softgel capsules or a identical looking placebo twice daily. 63 volunteers received 200mg palm vitamin E (tocotrienols) and the remaining 57 received placebo. They were followed up every 3 months for a period of 1 year for their blood biochemistry profile and MRI of the brain was conducted at baseline and 12 months.
Individuals randomized in the (MRI+ve) and (MRI -ve) cohort respectively. In the MRI(+ve) cohort, 62 subjects received 200 mg softgels of Palm Vitamin E (tocotrienols) and 59 were assigned to placebo, taken orally twice a day for a study period of two years. In the MRI(-ve) cohort, 63 subjects received 200 mg softgels of Palm Vitamin E (tocotrienols) and 57 consumed placebo, taken twice a day for a follow up period of 1 year.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kepala Batas Hospital
Kepala Batas, Pulau Pinang, 13200, Malaysia
Gopalan Y, Shuaib IL, Magosso E, Ansari MA, Abu Bakar MR, Wong JW, Khan NA, Liong WC, Sundram K, Ng BH, Karuthan C, Yuen KH. Clinical investigation of the protective effects of palm vitamin E tocotrienols on brain white matter. Stroke. 2014 May;45(5):1422-8. doi: 10.1161/STROKEAHA.113.004449. Epub 2014 Apr 3.
Magosso E, Ansari MA, Gopalan Y, Shuaib IL, Wong JW, Khan NA, Abu Bakar MR, Ng BH, Yuen KH. Tocotrienols for normalisation of hepatic echogenic response in nonalcoholic fatty liver: a randomised placebo-controlled clinical trial. Nutr J. 2013 Dec 27;12(1):166. doi: 10.1186/1475-2891-12-166.
Yuen Kah Hay, Phd
Universiti Sains Malaysia
241 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2008
First Posted
September 16, 2008
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis
Contact the study team to confirm eligibility.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
May 25, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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