Home » Trials » SLCTR/2015/018
A Randomised Control Trial of Virgin Coconut Oil in the Treatment of Alzheimer’s Dementia (VCO-AD Study).
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SLCTR Registration Number
SLCTR/2015/018
Date of Registration
The date of last modification
Jun 30, 2020
Scientific Title of Trial
A Randomised Control Trial of Virgin Coconut Oil in the Treatment of Alzheimer’s Dementia (VCO-AD Study).
Public Title of Trial
Use of virgin coconut oil in the treatment of Alzheimer's dementia
Disease or Health Condition(s) Studied
Alzheimer's disease
Scientific Acronym
VCO-AD RCT
Public Acronym
VCO-AD study
Brief title
RCT on virgin coconut oil and Alzheimer's disease
Universal Trial Number
U1111-1172-5083
Any other number(s) assigned to the trial and issuing authority
ERC Kelaniya Ref. P/116/06/2015
What is the research question being addressed?
What is the efficacy of virgin coconut oil (VCO) compared to placebo (canola oil) in improving cognition in patients with mild to moderate Alzheimer’s disease (AD)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
A double blind randomized trial will be conducted in patients with mild to moderate dementia. Patients will be allocated to two arms.
Arm 1 (intervention) will be administered 15ml virgin coconut oil (liquid, orally) twice daily for 24 weeks.
Arm 2 (control) will be administered 15ml canola oil (liquid, orally) twice daily for 24 weeks.
Standard treatment will be continued during the trial. The patients will continue follow up by their respective physicians and will continue their usual medical treatment. The patient as well as the treating clinician and those conducting assessments will be blind to treatment status.
Inclusion criteria
Mild-moderate AD in terms of NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria
Mini Mental State Examination (MMSE) score of 15 or above
Exclusion criteria
Primary outcome(s)
|
1.
Change in MMSE and Montreal - Cognitive Assessment (MoCA) scores |
[ Baseline, 24 weeks and one year ] |
Secondary outcome(s)
|
1.
Change in CLOX TEST (Clock drawing test) score |
[ Baseline, 24 weeks and one year ] |
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-10-01
Anticipated end date
2017-09-30
Date of first enrollment
2016-09-02
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
Coconut Research Institute, Sri Lanka (Ref. CRI/ACCT/2014/04)
Regulatory approvals
Status
Approved
Date of Approval
2015-07-14
Approval number
P/116/06/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Shehan Williams
Senior Lecturer
Department of Psychiatry, Faculty of Medicine, University of Kelaniya.
0112961115
0774301303
shehanwil@msn.com
Contact Person for Public Queries
Malika Fernando
Doctoral student
Department of Psychiatry, Faculty of Medicine, University of Kelaniya.
0112961115
0779350329
malikagayathri@gmail.com
Primary study sponsor/organization
Coconut Research Institute
Bandirippuwa Estate, Lunuwila
61150, Sri Lanka
0312255300
0312257688
www.cri.gov.lk
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
