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Clinical trial of comparison of vitamin D and placebo on serum level of inflammatory and anti-inflammatory cytokines in patients with sepsis

Protocol summary

Summary
Objectives: Clinical trial of comparison of vitamin D and placebo on serum level of inflammatory and anti-inflammatory cytokines in patients with sepsis Design: Blocked randomized, double blind, clinical trial study, Single center, controlled placebo, Sample size 160 patients selected in 3 months and block randomized into two groups. Inclusion criteria: Age greater than 18 years old; sepsis diagnosis and infection source. Exclusion criteria: Calcium level greater than or equal to 10 mg/dl; Vitamin D intake during 7 days ago; History of parathyroid diseases; End stage renal disease (ESRD) Interventions: First (intervention) group receive, 300000 unit vitamin D (1 milliliter), Intramuscular (IM) as a single dose. Second (control) group receive, 1 milliliter normal saline as placebo, single dose, intramuscularly. Main outcome measures: Serum level of Ca, Vitamin D, Interleukin10 and tumor necrosis factor alpha will be checked 3 months after injection. Also, Duration of hospitalization in different wards and mortality rate will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090823552N8
Registration date: 2016-10-05, 1395/07/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-05, 1395/07/14
Registrant information
Name
Abolfazl Jokar
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 2134
Email address
dr.a.jokar@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Arak University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Clinical trial of comparison of vitamin D and placebo on serum level of inflammatory and anti-inflammatory cytokines in patients with sepsis
Public title
The effect of vitamin D on patients with Sepsis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age greater than 18 years old; Sepsis diagnosis and infection source; Patients satisfaction Exclusion criteria: Calcium level greater than or equal to 10 mg/dl; Vitamin D intake during 7 days ago; History of parathyroid diseases; Metabolic bone disease; Sarcoidosis; End stage renal disease (ESRD); Impending death; Pregnancy.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study the randomization was conducted with block randomization method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University Of Medical Science, Basij Square, Arak
City
Arak
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.ARAKMU.REC.1394.235

Health conditions studied

1

Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified

Primary outcomes

1

Description
Serum Ca level
Timepoint
3 months after injection
Method of measurement
mg/dl

2

Description
serum Vitamin D level
Timepoint
3 months after injection
Method of measurement
mg/dl

3

Description
Tumor necrosis factor alpha
Timepoint
3 months after injection
Method of measurement
ELISA

4

Description
Interleukin 10
Timepoint
3 months after injection
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group : These patients will received 1 milliliter vitamin D (300000 IU) ( institut Pasteur.Tehran .Iran ) , single dose, Intramuscularly.
Category
Treatment - Drugs

2

Description
Control group : These patients will received 1 ml intramuscular, single dose of normal saline as placebo.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Abolfazl Jokar
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak,Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Vice Chancellor for Research
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
Vali-e-Asr hospital
Full name of responsible person
Dr Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Markazi, Iran
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
dr.a.jokar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vali-e-Asr hospital
Full name of responsible person
Dr Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
dr.a.jokar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali-e-Asr hospital
Full name of responsible person
Dr Abolfazl Jokar
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3223 1104
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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