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Effect of high dose of vitamin D on mortality, length of stay and inflammatory markers on Covid 19 patients admitted in the intensive care unit

Protocol summary

Study aim
Effect of high dose of vitamin D on mortality, length of stay and inflammatory markers on Covid 19 patients admitted in the intensive care unit
Design
A parallel, double-blind, placebo controled, randomized clinical trial
Settings and conduct
This study will be done on 60 corona virus patients who admitted in intensive care unit at Golestan hospital. Participants will be divided two groups: Ampule vitamin D and placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 years and older patients, Willingness to cooperate, definitely diagnosis corona disease with positive RT-PCR and chest CT-Scan, level of vitamin D less than 30ng/dlit Exclusion criteria: Reluctance to continue cooperation, pregnant, breastfeeding, hospitalized less than 24 hour in intensive care unit, consumption omega3, vitamin A and D supplements during last month, hypoparathiroidism, hypercalcemia, sensitive to vitamin D, kinds of cancers, radiotherapy, chemotherapy, or immunotherapy, renal diseases, liver failure, patients who are
Intervention groups
Receiving 300,000 unit vitamin D ampule group and placebo group
Main outcome variables
Recovery process will be checked by SOFA and APACHE2 questionnaires. Also AST,ALT,ALKPH, CRP, ESR, WBC, FBS, IL-6, Vitamin D will be checked.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170827035936N2
Registration date: 2021-12-19, 1400/09/28
Registration timing: registered_while_recruiting

Last update: 2021-12-19, 1400/09/28
Update count: 0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 2052
Email address
zohreh.javadfar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-12, 1400/08/21
Expected recruitment end date
2022-02-10, 1400/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose of vitamin D on mortality, length of stay and inflammatory markers on Covid 19 patients admitted in the intensive care unit
Public title
Effect of vitamin D on Corona disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 years and older patients, Willingness to cooperate, definitely diagnosis corona disease with positive RT-PCR and chest CT-Scan, level of vitamin D less than 30ng/dlit
Exclusion criteria:
18 years and older patients, Willingness to cooperate, definitely diagnosis corona disease with positive RT-PCR and chest CT-Scan, level of vitamin D less than 30ng/dlit
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both of researcher and patients do not aware about allocating groups. For this purpose, the information gathered in the questionnaires is encoded by people other than the researcher or other key collaborators, so that the researcher and the participants in the plan do not encode and enter the computer during the categorization and placement of each individual in the intervention or control group.
Placebo
Used
Assignment
Parallel
Other design features
In this study both of patients and researcher are blind about kind of investigation (vitamin D or placebo) groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of Research of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti St., Oil Field, Facing Taleghani Hospital, Building No. 2 of Kermanshah University of Medical Sciences, Research and Research Branch
City
kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2021-11-07, 1400/08/16
Ethics committee reference number
IRKUMS MED.REC.1400.069

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
The proportion of mortality and the period of staying in intensive care unit
Timepoint
The beginning of study until discharging from intensive care unit
Method of measurement
(Acute Physiology And Chronic Health Evaluation II Score (APACHE II and (Sequential Organ Failure Assessment score (SOFA score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Injection of 300000 IU of vitamin D3, the beginning of study
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital in Imam Reza complex hospital
Full name of responsible person
Dr Shahram Bidhendi
Street address
Parastar street
City
kermanshah
Province
Kermanshah
Postal code
6714636856
Phone
+98 83 3427 6302
Email
Ali.Soroush.mhr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Vice– Chancellery of Research & Technology Affairs, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3837 0541
Email
rkhodarahmi@mbrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zohreh Javadfar
Position
Master of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
parastar street
City
kermanshah
Province
Kermanshah
Postal code
6714636856
Phone
0098 83 4276301
Email
zohre.javadfar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zohreh Javadfar
Position
Master of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
parastar street
City
kermanshah
Province
Kermanshah
Postal code
6714636856
Phone
0098 83 4276301
Email
zohre.javadfar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zohreh Javadfar
Position
Master of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
parastar street
City
kermanshah
Province
Kermanshah
Postal code
6714636856
Phone
0098 83 4276301
Email
zohre.javadfar@yahoo.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
there are not more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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