Determine the effect of Vit A supplementation on inflammatory markers in COVID-19 patient with cardiovascular disease history
Design
Controled randomized clinical trails with double blinded parallel group designed in 66 patient with effect size 0.5, α=0.05 certainly 10% lost the final sample size was 75 individuals.
Settings and conduct
The intervention will start in Tehran Heart Center. At first we include the admitted patients and we took a tub blood and then we start intervention for 2 weeks. All include patients are in CCU and post CCU units.
Participants/Inclusion and exclusion criteria
Include criteria: age: 30-70 years old; history of cardiovascular disease; PCR positive or ground grass viral pattern in chest CT scan. Exclusion criteria: the people with end stage renal disease or GFR<6; liver complications; consume vitamin A supplement; cancer disease; the people infected with bacterial and fungal disease; intubated patient; the patient with reaction for vitamin A supplementation or palcebo
Intervention groups
The vitamin A soft gel with two different dosage supplemented: dosage I: 2600 IU is considered RDA dosage supplementation daily; dosage II: 25000 is IU pharmacological dosage supplementation 3 time a week
group; 3: the Paraffin consider as placebo.
Main outcome variables
Retinol and Vitamin D; ESR; CRP; pro calcitonin; WBC; lymphocyte; neutrophil; IL-6 and platelet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200826048535N1
Registration date:2021-08-13, 1400/05/22
Registration timing:retrospective
Last update:2021-08-13, 1400/05/22
Update count:0
Registration date
2021-08-13, 1400/05/22
Registrant information
Name
Mohammad Gholizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7627 8825
Email address
mghomid135@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-24, 1399/08/03
Expected recruitment end date
2021-01-28, 1399/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin A supplementation on blood inflammatory markers in COVID-19 patient with heart failure
Public title
The vitamin A supplementation in COVID-19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The individual age between 30-70 year
The people with history of cardiovascular disease
The COVID-19 people with PCR positive or Chest CT scan with ground glass viral pattern
Exclusion criteria:
The end stage renal disease people or GFR<60
The people with liver disease
Intubate or end stage disease people
The people with consumption vitamin A supplement
The patients that suffering cancer disease or chemo-radio therapy
The hemodialysis patient GFR<20
The people infected to bacterial or fungal disease
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
75
More than 1 sample in each individual
Number of samples in each individual:
1
At the first and in the end of intervention we take 10 cc blood from patients in simple test tube.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized by permited block stratified method (two intervention groups and one placebo group). Quadruple blocks based on sex variable into one of 3 groups 1: Treatment (RDA: VIT A 25000 unit /Three times a week, N=25 ) Group 2: Treatment (2600 International Vitamin A Unit/daily, N=25 ) Group 3: Control (Placebo: daily, N=25), randomly assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
The vitamin A soft gel in three dosage, like in color, size and figure divide in three CCU ward where the COVID-19 patient with similar condition admitted. Neither nurses nor patients not aware about content or dosage of vitamin A softgel or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Tehran university of medical science
Street address
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences (TUMS), Hojat Dost Alley, Naderi street, Keshavarz Blvd
City
تهران
Province
Tehran
Postal code
14155-6117
Approval date
2020-09-25, 1399/07/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.549
2
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medica Sciences, Poursina street, Qods street, Engelab Square
City
Tehran
Province
Tehran
Postal code
141556117
Approval date
2020-09-21, 1399/06/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.549
Health conditions studied
1
Description of health condition studied
Corona-virus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
2
Description of health condition studied
Cardiovascular disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
C-Reactive Protein
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
2
Description
Erythrocyte Sedimentation Rate
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
3
Description
Platelet
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
4
Description
Neutrophil
Timepoint
Before the supplementation and 2 weeks after supplementation.
Method of measurement
By taking10-15 cc blood from individuals
5
Description
White blood cells
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
6
Description
Lymphocyte
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
7
Description
Lipid profile
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
8
Description
25-Hydroxy Vitamin D
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
9
Description
Retinol
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
10
Description
Partial Thromboplastin Time
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
By taking10-15 cc blood from individuals
11
Description
Prothrombin Time
Timepoint
Before the supplementation and 2 weeks after supplementation
Method of measurement
Taking10-15 cc blood from individuals
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A: the participant intake 25000 IU vitamin A 4 softgel/week
Category
Treatment - Drugs
2
Description
Intervention group: Group B. the participant intake vitamin A 2600 IU, 7 softgel/ 7 day.
Category
Treatment - Drugs
3
Description
Control group: Group C: the participant intake one softgel daily for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Khadijeh Mirzaei
Street address
tehran heart center, north Kargar
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8802 9600
Email
mghomid135@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Khadijeh Mirzaei
Street address
Tehran Heart Center, North Kargar
City
Tehran
Province
Tehran
Postal code
1411713738
Phone
+98 21 8802 9731
Email
mghomid135@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
Proportion provided by this source
80
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
Khadijeh Mirzaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5569
Email
mirzaei_kh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Mirzaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences , Hojat Dost Alley, Naderi street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5569
Email
mirzaei_kh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Gholizadeh
Position
Master of Nutrition and Dietectic
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences , Hojat Dost Alley, Naderi street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5569
Email
mghomid135@gmail.com
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
Undecided - It is not yet known if there will be 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