the aim of this study was to evaluate the hypothesis that injection of vitamin D3 300,000 IU compared with placebo can reduce the muscle mass loss process in patients with sepsis that were admitted to intensive care unit during hospitalization
Design
َA 12-month prospective, randomized, double-blind study with two groups of case and contral was conducted on 46 patients. patients were enrolled between December 2016 to November 2017
Settings and conduct
Emam Reza Hospital ICU, double blinded with placebo (1 cc Normalin Saline)
Participants/Inclusion and exclusion criteria
Inclusion criteria were Adult adult (≥18 yrs. old), critically ill patients within 24 hours of new-onset sepsis, who had three out out of four criteria used to explain the systemic inflammatory response syndrome and who were admitted to Imam Reza Hospital, ICU and were expected to stay in the ICU for at least 48 hours from November 2016 to December 2017.
Intervention groups
24 patients received a single dose of 300,000 units VitD3 intramuscular injection
Main outcome variables
Sarcopenic Index, serum creatinine level, cystatin C serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150621022852N3
Registration date:2018-11-29, 1397/09/08
Registration timing:retrospective
Last update:2018-11-29, 1397/09/08
Update count:0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44429613
Email address
dr.s.asaadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-01, 1395/08/11
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
2016-11-01, 1395/08/11
Actual recruitment end date
2017-12-01, 1396/09/10
Trial completion date
2017-12-29, 1396/10/08
Scientific title
Effect of single dose Vitamin D3 Injection on Kidney Function and Muscle Mass in Sepsis Patients
Public title
effect of VitD3 on Kidney and Muscle in Sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill patients within 24 hours of new-onset sepsis
Had three out out of four criteria used to explain the systemic inflammatory response syndrome
Were expected to stay in the ICU for at least 48 hours
Exclusion criteria:
Acute Kidney Injury
At least two risk factors for AKI
Rapidly changing GFR
Rapidly changing serum creatinine
Rapidly changing cystatin C
Pregnancy
History of organ transplantation
Hypercalcemic (ionized calcium>1.3 mmol/L)
Maintenance renal replacement therapy
Platelets <30,000 per mm3 (Coagulopathy)
International normalized ratio > 3 (Coagulopathy)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
Actual sample size reached:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized using a random number generator to get an IM injection of vitamin D3
Blinding (investigator's opinion)
Double blinded
Blinding description
Medical staff of ICU who were unaware of randomization injected vitaminD or placebo. Apart from vitD3 injection, other cilinical aspects were same beween the two groups. As the patients and staff were blinded, we had no placebo effect
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Hajiesmaeili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Critical Care Medicinel
Street address
Qazvin St. Makhsus St.
City
Tehran
Province
Tehran
Postal code
8916835837
Phone
+98 21 5541 0044
Email
m.hajiesmaeili2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Hajiesmaeili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Critical Care Medicine
Street address
Qazvin St. Makhsus St
City
Tehran
Province
Tehran
Postal code
8916835837
Phone
+98 21 5541 0044
Email
m.hajiesmaeili2018@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Roozbeh
Position
resident of medicine
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Makhsous st,South kargar st, Enghelab sq
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5182
Email
mehrdadroozbeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information about the outcome of the study, will be available after concealment.
When the data will become available and for how long
One year after the publication of the study results
To whom data/document is available
Researchers and university students of related fields can access the data after passing the administrative process.
Under which criteria data/document could be used
A study observer appointed by the ethics committee of Shahid Beheshti University of Medical Sciences can request to receive data after being unidentifiable in order to control the ethical aspects of the study.
From where data/document is obtainable
Head of the Center for Development of Clinical Research - Management of Loghman Hakim Hospital
What processes are involved for a request to access data/document
To receive data, please contact the Loghman Hakim Hospital Clinical Development Center. After obtaining permission from the Head of the Research Center and then the Loghman Hakim Hospital, access to patient information and study will be provided.