The overall objective of this study is to investigate the effect of high-dose vitamin D3 on mortality, complications, length of stay in ICU and mechanical ventilation duration in pulmonary ICU patients.
The specific objectives are:
Comparison of length of stay in the ICU ,
mechanical ventilation duration,
mortality and morbidity rates
and in-hospital complications in two study groups.
this study is a double-blind, controlled clinical trial.
Inclusion criteria Consist of :ICU admissions with mechanical ventilation, length of stay in ICU more than 48 hours and 25-hydroxy vitamin D levels less than 20 ng /ml.
Exclusion criteria Consist of :age younger than 18 years on admission to ICU, length of stay in ICU less than 48 hours ; 25-hydroxy vitamin D levels More than 20 ng/ml.
For Patients in the intervention group 600,000 units of intramuscular vitamin D3 Will be injected without any intervention in control group .
Total and ionized calcium and serum 25-hydroxy vitamin D levels in the third, seventh and fourteenth days after administration of vitamin D3 will be measured and length of stay in ICU, duration of mechanical ventilation, mortality and mortality rates according to their records will be analyzed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050517583N1
Registration date:2015-02-19, 1393/11/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-19, 1393/11/30
Registrant information
Name
Haleh Mikaeili
Name of organization / entity
Tabriz University of Medical Scince
Country
Iran (Islamic Republic of)
Phone
+98 413347054
Email address
mikaeilih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose Vitamin D3 on mortality, morbidity, length of stay in ICU and mechanical ventilation duration in pulmonary ICU patients.
Public title
Effect of high dose Vitmin D on mortality and morbidity in pulmonary ICU patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ICU admissions with mechanical ventilation, ICU length of stay more than 48 hours; 25-hydroxy vitamin D levels less than 20 ng /ml.
Exclusion criteria:Age Younger than 18 years on admission to ICU; ICU length of stay less than 48 hours ; 25-hydroxy vitamin D levels More than 20 ng /ml.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht street,Tabriz University of Medical Sciences ,central building
City
Tabriz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
5/4/8145
Health conditions studied
1
Description of health condition studied
Respiratory faillure
ICD-10 code
j96
ICD-10 code description
Respiratory failure, not elsewhere classified
Primary outcomes
1
Description
calcium total and ionized
Timepoint
0,3,7,14 days after vitd injection
Method of measurement
serum level
2
Description
25OH Vit D
Timepoint
0,3,7,14 days after vitd injection
Method of measurement
Serum level
3
Description
Duration of mechanical ventilation
Timepoint
Until discharge from hospital
Method of measurement
Records of patient
Secondary outcomes
1
Description
Mortality
Timepoint
Until discharge from hospital
Method of measurement
Observations and records of patient
2
Description
Hospitalization days
Timepoint
Until discharge from hospital
Method of measurement
Observations and records of patient
3
Description
Hospital complications
Timepoint
Until discharge from hospital
Method of measurement
Observations and records of patient
Intervention groups
1
Description
In intervention group single dose of 600,000 units of vitamin D3 will be injected intramuscular.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr mikaeili Haleh
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hassan Soleimanpour
Street address
Golgasht Street ,Tabriz University of Medical Sciences ,central building II,third floor
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz medical siense university
Full name of responsible person
Dr. Mikaeili-haleh
Position
Associate Professor
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht Ave
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
Mikaeilih@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz medical science university
Full name of responsible person
Dr Mikaeili Haleh
Position
Associate Professor
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht Ave
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
Mikaeilih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz medical scince university
Full name of responsible person
Dr Mikaeili Haleh
Position
Associate Professor
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht Ave
City
Tabriz
Postal code
Phone
+43 3357 310
Fax
Email
Mikaeilih@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)