Home » Trials » SLCTR/2018/019
Synergistic Effects of delta-Tocotrienol, Resveratrol and Vitamin D Supplementation on Modulation of Biochemical Markers, Cytokines and miRNAs in patients of type 2 diabetes mellitus
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SLCTR Registration Number
SLCTR/2018/019
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Synergistic Effects of delta-Tocotrienol, Resveratrol and Vitamin D Supplementation on Modulation of Biochemical Markers, Cytokines and miRNAs in patients of type 2 diabetes mellitus
Public Title of Trial
Effects of delta-tocotrienol, resveratrol and vitamin D supplementation mixture on biochemical markers in diabetic patients
Disease or Health Condition(s) Studied
Type 2 Diabetes mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Effects of delta-tocotrienol, resveratrol and vitamin D supplementation mixture on biochemical markers in diabetic patients
Universal Trial Number
U1111-1215-3775
Any other number(s) assigned to the trial and issuing authority
Ethics Review Committee, Armed forces institute of pathology (AFIP); PhD-Path-18-02/Read-IRB/247
What is the research question being addressed?
Are delta tocotrienol, resveratrol and vitamin D combination effective in improving glyceamic control, reducing oxidative stress and inflammation in patients with type 2 diabetes mellitus?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study will be conducted at Armed forces Institutes of Pathology (AFIP), National University of Medical Sciences Rawalpindi, Pakistan.
The diabetic patients after screening will be assigned to one of the five groups by simple randomization. Five groups consisting of four treatment arms A,B,C, D and one control arm E. Allocation concealment technique will not be used.
All participants (diabetic patients) will be provided nutritional supplements along with their recommended oral hypoglycemic medications.
Participants of Group A will be given one capsule of delta-tocotrienol (250 mg/ day); Group B resveratrol (200mg/day) ; Group C vitamin D (2500 IU/day); Group D combination preparation of tocotrienol, resveratrol & vitamin D (250mg+150mg+ 2500 IU per day) and Group E Placebo-(400mg, cellulose) by oral route for 24 weeks
Details of each allocation arm in the factorial assignment is as follow Arm 1: delta tocotrienol + placebo Arm 2: vitamin D + placebo Arm 3: resveratrol + placebo Arm 4: delta tocotrienol+ vitamin D+ resveratrol+ Placebo Arm 5: Placebo
Diabetic management standard protocol of dietary control and oral hypoglycemic agents will be given to each arm of patients.
Masking will be carried out as follows:
Participants: Blinded
Healthcare providers: Blinded
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
To determine the improvement in the glycemic control, reduction of oxidative stress and inflammation in the patients of type II diabetes mellitus by measuring following biochemical markers: 1. Mean reduction from baseline in glycosylated hemoglobin (HbA1c) at 24 weeks
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[ From baseline to 24 weeks of treatment within all groups ] |
Secondary outcome(s)
|
1.
Mean change in insulin resistance as measured by HOMA-IR |
[ From baseline to 24 weeks of treatment within all groups ] |
Target number/sample size
275 individuals (55 patients in each group)
Countries of recruitment
Pakistan
Anticipated start date
2018-07-01
Anticipated end date
2019-01-31
Date of first enrollment
2018-06-28
Date of study completion
Recruitment status
Recruiting
Funding source
Higher Education Commission (HEC), Pakistan
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-04-05
Approval number
PhD-Path-18-02/Read-IRB/247
Details of Ethics Review Committee
| Name: | Institutional Review Board, Armed Forces Institute of Pathology |
| Institutional Address: | Rawalpindi, Pakistan |
| Telephone: | Not available |
| Email: | Not available |
Contact person for Scientific Queries/Principal Investigator
Dr. Dilshad Ahmed Khan
Professor of Pathology
National University of Medical Sciences (NUMS), Islamabad
0519270676
92-3005147938
dakhan@cpsp.edu.pk
Contact Person for Public Queries
Dr. Wajiha Mah Jabeen
PhD Scholar
Armed forces institute of Pathology (AFIP), National University of Medical Sciences (NUMS), Islamabad
03334219210
doctor_wajeeha@yahoo.com
Primary study sponsor/organization
Higher Education Commission (HEC) Pakistan
Head Office, Sector H-9, East Service Road, Islamabad
Pakistan
Tel: (051) 9040 0000 (051) 9040 0000
info@hec.gov.pk
http://www.hec.gov.pk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
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
