Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial
Assessment of boron-containing compounds and Oleoylethanolamid Supplementation on recovery trend in Patients with Known COVID-19
Design
Randomized clinical trial with parallel group trial, double-blinded ,first phase carried out on 40 Covid-19 patients. Randomization was carried out with rand function at an excel software.
Settings and conduct
Patients were randomly divided into 4 groups. The first group receive two capsule containing 5 mg boron compounds per day ,The second group receive two capsule containing 200 mg Oleoylethanolamide per day ,The third group receive two capsule containing 5 mg boron compounds with 200 mg Oleoylethanolamide per day and the fourth group receive two placebo tablets. the participants and researchers were blinded for intervention types during the study period.The groups will be compared in terms of patient recovery rate and hospital admission rate, vital signs and biochemical parameters such as CBC, ESR, CRP before and after the intervention.
Participants/Inclusion and exclusion criteria
Patients with Known COVID-19
Intervention groups
1. Receiving boron containing compound supplement:daily 2 capsules including 5 mg boron containing compound for two weeks
2.Receiving oleoylethanolamide supplement:daily 2 capsules including 200 mg oleoylethanolamide for two weeks
3. Receiving oleoylethanolamide and boron containing compound supplement:daily 2 capsules including 200 mg oleoylethanolamide and 5 mg boron for two weeks
4. Receiving placebo: daily 2 capsules including starch
Main outcome variables
recovery rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090609002017N35
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial
Public title
Assessment of boron-containing compounds and Oleoylethanolamid supplementation in the treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Known COVID-19
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals with inclusion criteria divided into intervention and control groups using Random allocation software (RAS).
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention and control groups individuals and main researcher do not know the type of supplements.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Nutrition Research Center, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.TBZMED.REC.1399.099
Health conditions studied
1
Description of health condition studied
COVID ‐ 19
ICD-10 code
U07.01
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Recovery trend
Timepoint
At baseline and at the end of intervention
Method of measurement
Examination
2
Description
Hospital admission time
Timepoint
At baseline and at the end of intervention
Method of measurement
Observation
3
Description
CBC,ESR
Timepoint
At baseline and at the end of intervention
Method of measurement
Blood sampling and testing with H1 device
4
Description
CRP
Timepoint
At baseline and at the end of intervention
Method of measurement
Blood sampling and measurement with Auto analyzer device
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 consume 2 capsules containing 5 mg boron containing compound per day for two weeks.
Category
Treatment - Drugs
2
Description
Group 2 consume 2 capsules containing 200 mg oleoylethanolamide per day for two weeks
Category
Treatment - Drugs
3
Description
Group 3 consume 2 capsules containing 5 mg boron containing compound and 200 mg oleoylethanolamide per day for two weeks
Category
Treatment - Drugs
4
Description
Group 4 as a control group consume 2 placebo capsules containing starch powder per day for two weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Alireza Ostadrahimi
Street address
Imam Reza Hospital, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3347 0549
Email
info@darc.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Nutrition Research Center, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 2292
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 2292
Email
ostadrahimi@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All data are resulting from Research project and will be used just for manuscript printing in academic journals.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available