Evaluation of the effect of Kefir produced from cow's milk on the clinical outcomes and immune response of patients with COVID-19; a randomized clinical trial
The goal of this study was to determine the effect of Kefir supplementation of on clinical outcomes and immune response in COVID-19 patients.
Design
A double-blind randomized controlled clinical trial with a sample size of 100 patients
Settings and conduct
In this study, 100 adult patients with the criteria of being infected with COVID-19 after being admitted to the Corona Ward of Tehran Army Hospital 503 were selected based on the entry criteria and randomly entered into 2 study groups.
Participants/Inclusion and exclusion criteria
Hospitalized patients diagnosed with COVID-19
Intervention groups
In the intervention group, participants received kefir grains (2-10%) to milk twice a day (250 ccs each time) for two weeks.
Main outcome variables
Inflammatory factors and clinical status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221106056423N1
Registration date:2022-11-27, 1401/09/06
Registration timing:registered_while_recruiting
Last update:2022-11-27, 1401/09/06
Update count:0
Registration date
2022-11-27, 1401/09/06
Registrant information
Name
Ramin Gooruee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 2952
Email address
ramingooruee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Kefir produced from cow's milk on the clinical outcomes and immune response of patients with COVID-19; a randomized clinical trial
Public title
Evaluation of the effect of Kefir produced from cow's milk on the treatment process and immune response of patients with Corona virus 2019 (COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive PCR-test confirming COVID-19 infection
Having a moderate or severe level of the disease
ICU patients (provided that there is no restriction on the consumption of certain food substances)
Age between 20-60 years
Administering 2 doses of Sinopharm vaccine
Absence of food allergies
Exclusion criteria:
Pregnancy or lactating
Use of anti-coagulant drugs
No infection with the Covid-19 virus
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
West Fatemi St. - Shahid Etemadzadeh St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-12-22, 1400/10/01
Ethics committee reference number
IR.AJAUMS.REC.1400.252
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Fever
Timepoint
At the baseline and end of the intervention
Method of measurement
Thermometer
2
Description
C-Reactive Protein
Timepoint
At the baseline and end of the intervention
Method of measurement
kit (Bionik, Iran) with the BT3500 (Biotecnica Instruments SpA -Italy) auto-analyzer
3
Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
At the baseline and end of the intervention
Method of measurement
Westergren Method
4
Description
Dyspnea
Timepoint
At the baseline and end of the intervention
Method of measurement
Clinical examintation
Secondary outcomes
1
Description
Gastrointestinal symptoms
Timepoint
At the baseline and the end of the intervention
Method of measurement
Clinical examination
2
Description
WBC
Timepoint
At the baseline and the end of the intervention
Method of measurement
Sysmex K-1000 Hematology Analyzer
Intervention groups
1
Description
Intervention group: Giving 250 cc of kefir (twice a day) along with following the hospital diet for 14 days.
Category
Treatment - Other
2
Description
Control group: No intervention with kefir and only following the hospital diet for 14 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Faezeh Bani Yaghubi
Street address
501 Army Hospital, above the Embassy of Pakistan, Etamadzadeh St., Fatemi West St., Tehran
City
Tehran
Province
Tehran
Postal code
1415613120
Phone
+98 21 8609 6350
Email
committe.aja@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Saeid Hadi
Street address
Tehran - West Fatemi St. - Shahid Etemadzadeh St
City
Tehran
Province
Tehran
Postal code
1415613121
Phone
+98 21 8609 6350
Email
committe.aja@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Ramin Gooruee
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
دانشگاه علوم پزشکی آجا
City
Tehran
Province
Tehran
Postal code
1415613121
Phone
+98 21 4382 2952
Fax
Email
ramingooruee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ramin Gooruee
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Artesh University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1415613121
Phone
+98 21 4382 2952
Fax
Email
ramingooruee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ramin Gooruee
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Artesh University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1415613121
Phone
+98 21 4382 2952
Fax
Email
ramingooruee@gmail.com
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