Protocol summary

Study aim
Determining the effect of vitamin D supplements on oxidative stress markers and weaning from mechanical Ventilatory Traumatic patients admitted to intensive acre unit
Design
In this randomized clinical trial, 72 patients, 18-65 years old, undergoing mechanical ventilation in the intensive care unit, were randomly divided into two intervention groups and one control group.
Settings and conduct
This single-blind study will be performed on patients undergoing mechanical ventilation in the intensive care unit of Urmia Imam Khomeini Hospital. Patients will be randomly assigned to 3 groups (the first group will be vitamin D, the second group will be vitamin D and the third control group). The study will be single-blind so that patients will not be informed about which groups will be assigned.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-65 years undergoing mechanical ventilation with a serum vitamin D level of between 10-30 ng/ml. Exclusion criteria: patients with chronic and acute renal failure, hemodialysis or peritoneal dialysis and GCS less than 9.
Intervention groups
Patients in the intervention groups will receive 50000 units of vitamin D for 6 consecutive days or vitamin D 300,000 units in muscle once. The control group will not receive any intervention.
Main outcome variables
SOFA(Sequential Organ Failure Assessment Score); Mechanical ventilation duratin; Admitted duration; Mortality; Body composion; IL6 serum level; 7- TAC (Total Antioxidan Capacity) serum level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171221037983N1
Registration date: 2018-01-11, 1396/10/21
Registration timing: registered_while_recruiting

Last update: 2018-01-11, 1396/10/21
Update count: 0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Mohammad Amin Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
valizademohammadamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Vit D supplementation on oxidative stress markers and weaning from mechanical Ventilatory Traumatic patients
Public title
Assessment of the effect of Vit D supplementation in mechanical Ventilatory Traumatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All mechanical Ventilatory Traumatic patients admitted to intensive acre unit The age group 18-65 years Vit D serum level between 10-3 ng/ml Minimum length of stay 7 days in ICU
Exclusion criteria:
Patients with chronic and acute renal failure Patients under hemodialysis or peritoneal dialysis GCS<9
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
More than 1 sample in each individual
Number of samples in each individual: 1
Each participant will provide a sample for study.
Randomization (investigator's opinion)
Randomized
Randomization description
Using statistical software, patients will be randomly assigned to the intervention groups and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
this study will be carried out single blind so that the patient is unaware.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Ershad Ave, Modarres Blvd, Imam Khomeini Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.UMSU.REC.1396.288

Health conditions studied

1

Description of health condition studied
Traumatic patients
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
Oxidative Stress: determining the total antioxidant capacity and IL6 serum levels
Timepoint
Baseline-7 days after intervention
Method of measurement
ELISA Test

2

Description
SOFA (Sequential organ failure assessment score)
Timepoint
Baseline-7 days after intervention
Method of measurement
checklist

Secondary outcomes

1

Description
Body composition
Timepoint
Baseline- after 7 days from intervention
Method of measurement
body Analyzer Inbody

2

Description
mortality
Timepoint
end of study
Method of measurement
dead or live

Intervention groups

1

Description
Intervention group: 5000O IU oral Vitamin D for 6 consecutive days
Category
Treatment - Drugs

2

Description
Intervention group: Vitamin D 300,000 units are muscle and in a single dose
Category
Treatment - Drugs

3

Description
Control group: Patients will not receive the any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Amin Valizade
Street address
Ershad Ave, Modarres Blvd, Imam Khomeini Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3356 9935
Email
valizadeh.ma@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohebbi
Street address
Resalat Ave, Urmia University of Medical Sciences, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3223 1930
Email
mohebbi.i@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Valizade
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ershad Ave, Modarres Blvd, Imam Khomeini Hospital
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3346 9935
Email
valizadeh.ma@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Valizade
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ershad Ave, Modarres Blvd, Imam Khomeini Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3346 9935
Email
valizade.ma@umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Afsoon Eivazlou
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ershad Ave, Modarres Blvd, Imam Khomeini Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 44 3346 9935
Email
Eivazloo.Afsoon@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
Confidentiality of Participants Information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
The results will be shared on paper.
When the data will become available and for how long
One year after the completion of the project.
To whom data/document is available
Researchers
Under which criteria data/document could be used
Reaserchers
From where data/document is obtainable
Emial: valizadeh.ma@umsu.ac.ir
What processes are involved for a request to access data/document
Request access via email
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