The effect of oral medium-chain triglyceride (MCT) on prognosis and outcome of outpatients suspected COVID-19 in Kerman medical centers
Design
A randomized controlled clinical trial with parallel groups
Settings and conduct
Eligible patients with mild to moderate disease according to The Corona Virus Guideline who visit the clinics designated by the Kerman department of Health for COVID-19, and candidate for quarantine and receive home treatment will enter to the study. Patients in both groups receive classical medicine according to the Corona Virus Guideline. Patients in the intervention group receive MCT Oil as well as classical medicine.
Participants/Inclusion and exclusion criteria
Patients with 18-65 years old, developing mild to moderate COVID-19 based on Ministry of Health protocol and candidate for outpatient treatment include to this study. No allergic to MCT (for those who have previously taken MCT and know they are allergic). Allergy to MCT Oil, Asthma or allergy Hypertension, Diabetes, Pregnancy/lactation, Congestive heart failure, Chronic renal failure, Chemotherapy, Taking Corticosteroid and Immune deficiency are excluded.
Intervention groups
Intervention group: receive medication for treatment of Covid-19 according to Ministry of Health Protocol with the administration of oral medium-chain triglyceride (MCT) Control group: receive medication for the treatment of Covid-19 according to Ministry of Health protocol
Main outcome variables
Temperature; Respiratory rate; cough ; weakness; and muscular pain
General information
Reason for update
Acronym
MCT
IRCT registration information
IRCT registration number:IRCT20160313027033N2
Registration date:2020-04-16, 1399/01/28
Registration timing:registered_while_recruiting
Last update:2020-04-16, 1399/01/28
Update count:0
Registration date
2020-04-16, 1399/01/28
Registrant information
Name
Mahdiyehsadat Eftekharafzali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 0360
Email address
m.eftekharafzali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral intermediate chain triglyceride on prognosis and course of disease in suspected outpatients with COVID-19
Public title
The effect of MCT Oil on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild or moderate COVID-19 disease according to the diagnostic protocol provided by the Ministry of Health
Exclusion criteria:
No allergic to MCT (for those who have previously taken MCT and know they are allergic).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and control groups using Random Allocation Software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.KMU.REC.1399.019
Health conditions studied
1
Description of health condition studied
Coronavirus COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Temperature
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Thermometer
2
Description
Cough (severity-frequency)
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Fisman Cough Severity Score
3
Description
Weakness
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Asking patients using visual analog scale (VAS)
4
Description
Respiratory rate
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Counting the number of breaths per minute
5
Description
Muscular pain
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Asking patients using visual analog scale (VAS)
6
Description
Urine Ketone
Timepoint
Four hours after taking MCT oil
Method of measurement
It is checked with a urine test strip.
Secondary outcomes
1
Description
Hospital admssion
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Ratio of the number of admission to total patients in each group
2
Description
Mortality
Timepoint
0-1-2-3-14 days after starting intervention
Method of measurement
Ratio of the number of deaths to total patients in each group
Intervention groups
1
Description
Intervention group: Patients in this group in addition to drug treatment according to the Ministry of Health protocol, take 2 tablespoons of medium-chain triglyceride (MCT) to cure fever with each meal. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive medication according to the Ministry of Health protocol. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman County Health Center
Full name of responsible person
Alireza Zahedi Neyestani
Street address
Shafa Crossroads, Kerman County Health Center
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 5600
Email
ali.zahedi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman university of medical sciences, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Zahedi Neyestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Crossroad Amirkabir, Jomhuri eslami Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
ali.zahedi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Setayesh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Crossroad Amirkabir, Jomhuri eslami Blvd
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
msetayeshmail@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdiyehsadat Eftekharafzali
Position
Specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Crossroad Amirkabir, Jomhuri eslami Blvd
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
m.eftekharafzali@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared through a supplementary file after unidentified individuals.
When the data will become available and for how long
Start the access period from 6 months after printing results
To whom data/document is available
Researchers and other people can access data if they need it.
Under which criteria data/document could be used
For use in review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer.
From where data/document is obtainable
Executor of plan or University
What processes are involved for a request to access data/document
Email the scheduler (Dr.Setayesh) ,he answers.
Comments
All information is available to others for the advancement of science.