1. Home
  2. Approved trials
  3. » فارسی

Randomized clinical trial comparison of vitamin D and placebo in urosepsis

Protocol summary

Summary
Objectives: Comparison of vitamin D and placebo in urosepsis Design: Blocked randomized, double blind, Single center, controlled placebo, Sample size 100 patients Inclusion criteria: Age between 18 to 70 years old; sepsis diagnosis with urinary tract infection. 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: In first ( intervention ) group, 300000 unit vitamin D (1 milliliter), Intramuscular(IM) as a single dose, added to urosepsis standard treatment .In second (control ) group, 1 milliliter normal saline as placebo, IM, added to urosepsis standard treatment. Main outcome measures: Vital signs monitored every 6 hours until 72 hours and CBC, ESR, CRP, Creatinine, Urea and Uric Acid measured at baseline, 24, 48 and 72 hours after injection and serum level of Calcium, phosphorus and vitamin D measured at baseline and 72 hours after injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030223552N7
Registration date: 2016-10-15, 1395/07/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-15, 1395/07/24
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
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial comparison of vitamin D and placebo in urosepsis
Public title
The effect of vitamin D on urosepsis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 70 years old; Sepsis diagnosis with urinary tract infection; 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 to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
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, Markazi
City
Arak
Postal code
00
Approval date
2015-12-16, 1394/09/25
Ethics committee reference number
ir.arakmu.rec.1394.237

Health conditions studied

1

Description of health condition studied
sepsis
ICD-10 code
A41.5
ICD-10 code description
Sepsis due to other Gram-negative organisms

Primary outcomes

1

Description
White blood cell
Timepoint
every 24 hours to 72 hours
Method of measurement
Number per microliter

2

Description
Temperature
Timepoint
every 6 hours to 72 hours
Method of measurement
Thermometer

3

Description
ESR
Timepoint
Every 24 hours to 72 hours
Method of measurement
mm per hour

4

Description
Creatinine
Timepoint
Every 24 hours to 72 hours
Method of measurement
mg /dl

5

Description
CRP
Timepoint
Every 24 hours to 72 hours
Method of measurement
mg/dl

Secondary outcomes

1

Description
Systolic blood pressure
Timepoint
Every 6 hours to 72 hours
Method of measurement
Sphygmomanometer

2

Description
Diastolic blood pressure
Timepoint
Every 6 hours to 72 hours
Method of measurement
Sphygmomanometer

3

Description
Heart rate
Timepoint
Every 6 hours to 72 hours
Method of measurement
Pulse per minute

4

Description
Respiratory rate
Timepoint
Every 6 hours to 72 hours
Method of measurement
Respitation per minute

5

Description
Blood urea nitrogen ( BUN )
Timepoint
Every 6 hours to 72 hours
Method of measurement
mg / dl

6

Description
Calcium
Timepoint
At baseline and 72 hour after injection
Method of measurement
mg / dl

7

Description
Phosphorus
Timepoint
At baseline and 72 hour after injection
Method of measurement
mg / dl

8

Description
Vitamin D
Timepoint
At baseline and 72 hour after injection
Method of measurement
mg / dl

9

Description
Uric acid
Timepoint
Every 24 hours to 72 hours
Method of measurement
mg/dl

Intervention groups

1

Description
Intervention group : These patients receive 300000 IU vitamin D ( institut Pasteur.Tehran .Iran ) ,with 1 cc volume, Intramuscular
Category
Treatment - Drugs

2

Description
Control group : These patients receive 1 ml intramuscular normal saline as placebo.
Category
Placebo

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
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
Vice chancellor for research,Arak 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
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
City
Arak
Postal code
00
Phone
+98 86332222003
Fax
Email
dr.a.jokar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
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
City
arak
Postal code
00
Phone
+86 32222003
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, Markazi
City
Arak
Postal code
00
Phone
+98 86 3222 2003
Fax
Email
dr.a.jokar@gmail.com
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
Loading...