Home » Trials » SLCTR/2015/023
A randomized controlled, double blinded, clinical trial investigating the effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic fatty liver disease
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SLCTR Registration Number
SLCTR/2015/023
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized controlled, double blinded, clinical trial investigating the effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic fatty liver disease
Public Title of Trial
Effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic Fatty Liver Disease (NAFLD)
Disease or Health Condition(s) Studied
Nonalcoholic fatty liver disease (NAFLD)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1174-1454
Any other number(s) assigned to the trial and issuing authority
4-22-15/15/RDC/AFIP issued by Pakistan Medical Research Council (PMRC)
What is the research question being addressed?
Will delta-tocotrienol supplementation result in improvement in NAFLD by reducing insulin resistance and oxidative stress, as compared to placebo?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
The interventional product is Delta-tocotrienol, a natural Vitamin E compound that is available in the market as a dietary supplement.
Consenting participants fulfilling the inclusion/exclusion criteria will be randomized into two arms of 34 participants each.
Subjects in the group A will receive capsules containing the interventional agent [delta-tocotrienol 300mg (Riverside Pharmaceuticals, USA)]
Subjects in the group B will receive a matching capsule containing sucrose 50mg as placebo.
The capsules will be given in sealed envelopes. Subjects will be instructed to consume the contents of the envelopes twice daily for 24 weeks.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline,12 weeks and 24 weeks (end of trial) ] |
Secondary outcome(s)
|
1.
|
[ At baseline,12 weeks and 24 weeks(end of trial) ] |
Target number/sample size
68 (34 per group)
Countries of recruitment
Pakistan
Anticipated start date
2015-10-05
Anticipated end date
2016-04-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Armed Forces Institute of Pathology (Approval is in process)
Regulatory approvals
Status
Approved
Date of Approval
2015-05-28
Approval number
Not available
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Armed Forces Institute of Pathology Rawalpindi |
| Institutional Address: | Rawalpindi, Pakistan |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Professor Dilshad Ahmed Khan
Professor of Pathology
Department of Chemical Pathology and Endocrinology, AFIP Rawalpindi
Tel: +92 51 5563243
Mob: +92 300 5147938
schp-dakhan@cpsp.edu.pk
Contact Person for Public Queries
Dr. Muhammad Amjad
Postgraduate Student in Chemical Pathology
Department of Chemical Pathology and Endocrinology, AFIP Rawalpindi
Tel: +92 346 5506000
Mob: +92 346 5506000
dramjad282@yahoo.com
Primary study sponsor/organization
Armed Forces Institute of Pathology, Pakistan
Tamizuddin Road, Rawalpindi 46000, Pakistan
Tel: +92-51-9273649
Fax: +92-51-9271247
http://www.afip.org.pk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
