NCT01973400

Brief Summary

Given that the tocotrienols have been shown to possess neuroprotective effects and that both type 1 and type 2 diabetes can lead to peripheral neuropathy and cognitive impairment, the present study aims to determine the beneficial effects of tocotrienols in ameliorating such neurological related events in both type 1 and type 2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_3

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

June 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4.3 years

First QC Date

October 24, 2013

Last Update Submit

May 1, 2017

Conditions

Diabetic NeuropathyCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Total Symptoms Score (TSS) (pain, paresthesia, burning, and numbness)of patients with diabetes type 1 and 2 neuropathy.

    1 year

Secondary Outcomes (1)

  • Neuropathy Impairment Score (NIS) of patients with diabetes type 1 and 2 neuropathy

    1 year

Other Outcomes (1)

  • Mini Mental State Examination (MMSE) score, Montreal Cognitive Assessment (MoCA) test.

    1 year

Study Arms (2)

Tocotrienol

EXPERIMENTAL

200 mg, twice a day, 12 months

Dietary Supplement: Tocotrienol

Placebo

PLACEBO COMPARATOR

200 mg, twice a day, 12 months

Dietary Supplement: Placebo

Interventions

TocotrienolDIETARY_SUPPLEMENT

Palm-Oil derived Vitamin E, tocotrienol

Tocotrienol
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic adults ( both type 1 or 2) ≥20 years old with diabetic peripheral neuropathy with Total Symptom Score(TSS) ≥ 3 points.
  • Patients with type 1 diabetes (duration of ≥5 years).
  • Patients with type 2 diabetes (at diagnosis).
  • Patients with Neuropathy Impairment Score(NIS) \> 2

You may not qualify if:

  • Patients HbA1c \>12%.
  • Patients with hypoglycemia or conscious impairment at the time of test conduction.
  • Patients exhibiting symptoms of peripheral vascular disease with absence of 2 foot pulses on the same foot (Posterior tibialis, Dorsalis pedis)
  • Immuno-compromised patients.
  • Patients with severe visual impairment, history of psychosis; schizophrenia; bipolar disorder; current depression or brain trauma and patients with alcohol dependence or drug abuse such as cocaine, heroin, etc.
  • Those having lesions with a propensity to bleed (e.g., bleeding peptic ulcers), those having a history of hemorrhagic stroke and those with inherited bleeding disorders (e.g., hemophilia) or patients on warfarin.
  • Pregnancy and lactation.
  • Patients with renal function test of more than 150 umol/L (serum creatinine).
  • Patients with liver function test of more than 5 times of the upper normal range
  • Active infection or infectious diseases.
  • Other significant uncontrolled medical illnesses that may interfere with drug administration or interpretation of results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seberang Jaya Hospital

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Related Publications (1)

  • Vitamin E in Neuroprotection Study (VENUS) Investigators; Hor CP, Fung WY, Ang HA, Lim SC, Kam LY, Sim SW, Lim LH, Choon WY, Wong JW, Ch'ng ASH, Beh KKM, Wee HC, Ong LM, Khan NAK, Sulaiman SAS, Shuaib IL, Bakar A, Yusof Y, Yusof YM, Abu Bakar F, Tang WS, Teh HL, Wahid NA, Saaidin S, Idris N, Yoon CK, Ong HN, Ganapathy JT, Loo CE, Samy MM, Zainal H, Dharan SCS, Ooi BY, Teoh PY, Tye YL, Yeoh CA, Low DW, Looi I, Yuen KH. Efficacy of Oral Mixed Tocotrienols in Diabetic Peripheral Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):444-452. doi: 10.1001/jamaneurol.2017.4609.

    PMID: 29379943DERIVED

MeSH Terms

Conditions

Diabetic NeuropathiesCognitive Dysfunction

Interventions

Tocotrienols

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kah Hay Yuen, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 31, 2013

Study Start

June 1, 2011

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

MY(1)