NCT00753532

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 on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

4.3 years

First QC Date

September 15, 2008

Last Update Submit

May 18, 2022

Conditions

Cerebrovascular Disorders

Keywords

Carotid artery stenosesBrain ischaemiastrokeLipid abnormalitiesFatty Liver

Outcome Measures

Primary Outcomes (1)

  • Regression of white matter lesion load in terms of numbers and size in the brain

    1 to 2 years

Secondary Outcomes (3)

  • 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

Study Arms (2)

MRI(+ve),

PLACEBO COMPARATOR

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..

Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo

MRI(-ve)

PLACEBO COMPARATOR

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.

Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo

Interventions

200mg of Palm vitamin E (tocotrienols) or placeboDIETARY_SUPPLEMENT

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.

Also known as: Tocovid 200mg
MRI(+ve),MRI(-ve)

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepala Batas Hospital

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Related Publications (2)

  • 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.

    PMID: 24699052DERIVED

  • 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.

    PMID: 24373555DERIVED

MeSH Terms

Conditions

Cerebrovascular DisordersCarotid StenosisStrokeFatty Liver

Interventions

TocotrienolsTocovid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesArterial Occlusive DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Vitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yuen Kah Hay, Phd

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

November 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

MY(1)