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Investigation of simultaneous administration of biotin, brewer’s yeast, and vitamin C supplements on the improvement of clinical symptoms in patients with COVID-19

Protocol summary

Study aim
Due to the role of biotin, brewer's yeast, and vitamin C in improving the symptoms of diseases such as influenza and cold, the aim of the present study is to evaluate the effect of these supplements on the improvement of clinical symptoms associated with COVID-19.
Design
The clinical trial consists of a control group with parallel, non-blind, randomized, phase 3 on 50 patients and, a random number table will be used for randomization.
Settings and conduct
In this study, 50 male patients who have referred to Shariati Hospital with a positive chest CT scan for COVID-19 will be selected. After completing the consent form and questionnaire, patients will be divided randomly into two groups according to inclusion and exclusion criteria. In addition to their routine treatment, one group will receive three biotin tablets (5000 micrograms) on the first day, two biotin tablets (5,000 micrograms) on the second and third day, and one biotin tablet (5,000 micrograms) on the fourth to eighth days. In addition to biotin, one effervescent tablet of vitamin C (500 mg) and two tablets of brewer's yeast for 10 days will be received, daily. The control group will receive only routine Covid-19 treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 to 60 years; Male sex; Patients whose chest CT scan is positive for COVID-19; Exclusion criteria: Infectious diseases, cancer, and autoimmune diseases; Severe heart and liver diseases; Existence of severe clinical symptoms that require; hospitalization; Diabetes
Intervention groups
In addition to routine treatment, the intervention group will receive biotin, brewer's yeast, and vitamin C supplements for 10 days. The control group will have its own routine treatment.
Main outcome variables
Clinical symptoms improvement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201004048923N1
Registration date: 2020-12-13, 1399/09/23
Registration timing: registered_while_recruiting

Last update: 2020-12-13, 1399/09/23
Update count: 0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Shadi Seyyed Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3293
Email address
ebrahimi_sh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-15, 1399/07/24
Expected recruitment end date
2021-01-14, 1399/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of simultaneous administration of biotin, brewer’s yeast, and vitamin C supplements on the improvement of clinical symptoms in patients with COVID-19
Public title
Effect of biotin, brewer’s yeast and vitamin C supplements in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 60 years old Male sex COVID-19 patients with positive chest CT scan
Exclusion criteria:
Infectious diseases, cancer and autoimmune diseases Severe heart and liver diseases Existence of severe clinical symptoms that require hospitalization Diabetes
Age
From 20 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The stratification layer in this study is age. In order to allocate the same number of people in both groups, stratified randomization was used. Randomization of individuals into intervention and control groups was performed using a random number list created online by Random.org.This list is randomly divided between intervention and control groups from 1 to 50.
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 Tehran University of Medical Sciences
Street address
Bulding No 1, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.574

Health conditions studied

1

Description of health condition studied
Coronavirus disease 2019 (COVID-19)
ICD-10 code
U07. 1
ICD-10 code description
U07. 1

Primary outcomes

1

Description
Clinical symptoms improvement
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

Secondary outcomes

1

Description
Fever
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

2

Description
Chills
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

3

Description
Fatigue
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

4

Description
Cough
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

5

Description
Shortness of breath
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

6

Description
Headache
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

7

Description
Myalgia
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

8

Description
Earache
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

9

Description
Rhinorrhea
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

10

Description
Sore throat
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

11

Description
Diarrhea
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

12

Description
Nausea or vomiting
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

13

Description
Swelling
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

14

Description
Skin allergy
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

15

Description
Paleness of the fingers and toes
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

16

Description
Smell or taste loss
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

17

Description
Chest pain or discomfort
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

18

Description
Loss of the ability to move or speak
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

19

Description
Insomnia
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

20

Description
Sweating
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

21

Description
Anorexia
Timepoint
At the beginning of the study (before the intervention) and after receiving supplements, daily
Method of measurement
Patient statements during the phone call and recording information according to the scoring system designed in the checklist

Intervention groups

1

Description
Intervention group: Patients in this group, addition to their routine treatment will receive; first day: two biotin tablets (5000 micrograms) simultaneously and after that with at least 6 hours, one another biotin tablet (5000 micrograms), second and third days: two biotin tablets (5,000 micrograms) with at least 8 hours interval. Fourth day up to the end of intervention: one biotin tablet (5,000 micrograms) daily. In addition to biotin, one effervescent tablet of vitamin C (500 mg) and two tablets of brewer's yeast will be received, daily up to the end of intervention.
Category
Treatment - Drugs

2

Description
Control group: Control group will receive only routine COVID-19 treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital Emergency
Full name of responsible person
Dr Maliheh Paknejad
Street address
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3295
Email
paknejadma@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr Maliheh Paknejad
Street address
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3295
Email
paknejadma@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
By researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maliheh Paknejad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3295
Email
paknejadma@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maliheh Paknejad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3295
Email
paknejadma@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maliheh Paknejad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3295
Fax
Email
paknejadma@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Undecided - It is not yet known if there will be a plan to make this available
When the data will become available and for how long
Undecided - It is not yet known if there will be a plan to make this available
To whom data/document is available
Undecided - It is not yet known if there will be a plan to make this available
Under which criteria data/document could be used
Undecided - It is not yet known if there will be a plan to make this available
From where data/document is obtainable
Undecided - It is not yet known if there will be a plan to make this available
What processes are involved for a request to access data/document
Undecided - It is not yet known if there will be a plan to make this available
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