Determining the effects of vitamin B12 on clinical outcome and complications of hospitalized covid-19 patients.
Design
double blind randomized clinical trail. with control group, phase 3, 40 patients. block randomization
Settings and conduct
This study will be performed at Baharloo Hospital and patients will be given an oral vial of vitamin B-12. Also, the caregivers will be blind to the study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
consent
age 18-75 years
covid-19 patients
hospitalized patients
exclusion criteria:
consent not given
not within the 18-75 years old range
needing ventilator
acute/chronic kidney insufficiency
liver insufficiency
taking vitamin B12 in the past 3 months.
Intervention groups
in the first 24 hours of admissionthe level of vitamin B-12 will be checked and after that the oral vial of vitamin B-12 will be ordered for 7 days for covid-19 patients. control group will receive placebo with same volume.
Main outcome variables
Shortness of breath, ferritin, esr, crp, wbc, need for mechanical ventilation, mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210515051304N1
Registration date:2021-11-18, 1400/08/27
Registration timing:registered_while_recruiting
Last update:2021-11-18, 1400/08/27
Update count:0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
zahra erfani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3457 5525
Email address
zahraerfani1998@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-04, 1400/07/12
Expected recruitment end date
2021-12-03, 1400/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effects of vitamin B12 on clinical outcome and complications of hospitalized covid-19 patients.
Public title
Effect of vitamin B12 on hospitalized covid-19 patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
consent
age 18-75 years
covid-19 patients
hospitalized
Exclusion criteria:
nodding ventilator
acute/chronic renal insufficiency
liver insufficiency
taking vitamin b12 in the past 3 months
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
bock randomization
in order to balance the randomization and blindness, four block are randomized during the study. in each block, there are two groups and and as the group is completed, the first block will be opened and four patients will be assign according to the first block. then enter the second block until the sufficient sample.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and caregivers will not know whether the medication is a placebo or the drug.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences