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The Effect of Activated Vitamin D on treatment of Acute Kidney injury

Protocol summary

Study aim
Evaluation of the therapeutic effect of the active form of vitamin D in the treatment of patients with acute renal failure Renal type
Design
Patients were randomly divided into two groups of 38 using random allocation software. The numbered envelopes will be arranged from 1 to 76, respectively, and within each envelope the type of treatment is specified, which will be implemented after the treatment envelope is opened.
Settings and conduct
This double-blind parallel clinical trial study will be performed on acute renal failure patients referred to the emergency department of Imam Hossein Shahroud Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages over 18 years, Acute kidney failure according to KDIGO criteria, Having informed consent to participate in the study, Hospitalized in the usual ward, ICU CCU of Imam Hossein Shahroud Hospital, Non-return of creatinine to normal within 48 hours despite fluid replacement or granular and epithelial casts, Ability to eat or own NG Tube, No history of kidney disease and kidney transplant, No history of taking vitamin D compounds for the past 7 days, No active primary parathyroid disease or active granulomatous disease or symptomatic nephrolithiasis in the past 3 months, No pregnancy, no breastfeeding. Exclusion criteria: Administration of cytochrome p450 inhibitors, hemoglobin lower than 7
Intervention groups
The study will be randomly divided into two groups of 38. The case group received 0.25 mg rocanrolol tablets, except for routine renal injury treatment. In the control group, patients will receive no medication other than routine treatment of acute kidney injury.
Main outcome variables
Kidney function The blood urea and creatinine levels are measured

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181010041299N2
Registration date: 2019-10-31, 1398/08/09
Registration timing: registered_while_recruiting

Last update: 2019-10-31, 1398/08/09
Update count: 0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
mostafa enayatrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3961
Email address
mostafaenayatrad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Activated Vitamin D on treatment of Acute Kidney injury
Public title
The Effect of Activated Vitamin D on treatment of Acute Kidney injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages over 18 years Acute kidney failure according to KDIGO criteria Having informed consent to participate in the study Hospitalized in the usual ward, ICU CCU of Imam Hossein Shahrood Hospital Non-return of creatinine to normal within 48 hours despite fluid replacement or granular and epithelial casts Ability to eat or own NG Tube No history of kidney disease and kidney transplant No history of taking vitamin D compounds for the past 7 days No active primary parathyroid disease or active granulomatous disease or symptomatic nephrolithiasis in the past 3 months No pregnancy no breastfeeding
Exclusion criteria:
Get cytochrome p450 inhibitor drugs Hemoglobin less than 7
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into 38 groups using Random allocation software. The numbered envelopes will be arranged in the order of 1 to 76, respectively, and within each envelope the type of treatment is specified, which will be executed after the treatment envelope is opened.
Blinding (investigator's opinion)
Double blinded
Blinding description
To prevent patient awareness and the analyst of the study, each treatment group will be assigned a code that only the specialist program will know about their interpretation. The code commentary will be announced after analyzing the results
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Room 409. Third floor. medical School. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran
City
Shahroud
Province
Semnan
Postal code
Room 409. Third floo
Approval date
2019-08-17, 1398/05/26
Ethics committee reference number
IR.SHMU.REC.1398.053

Health conditions studied

1

Description of health condition studied
Acute Kidney Failure
ICD-10 code
N17.0
ICD-10 code description
Acute renal failure with tubular necrosis

Primary outcomes

1

Description
Evaluation of kidney function
Timepoint
Daily
Method of measurement
blood test

2

Description
urea
Timepoint
Daily
Method of measurement
blood test

3

Description
creatinine level
Timepoint
Daily
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The case group received 0.25 mg rocanrolol tablets, except for routine renal injury treatment.
Category
Treatment - Drugs

2

Description
Control group: patients will receive no medication other than routine treatment of acute kidney injury.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital, Shahroud, Semnan Province
Full name of responsible person
Dr. Asie Emmett Mohammadi
Street address
Imam Hossein Hospital. Imam Hossein Square. Shahroud. Iran
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5009
Email
asyomat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
Research Deputy, second floor, medical School, Shahroud University of Medical Sciences, Hafte-Tir Square, Tehran Avenue, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5009
Email
asyomat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Asie Emmett Mohammadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Room 409, Third floor, medical School, Shahroud University of Medical Sciences, Hafte-Tir Square, Tehran Avenue, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5009
Email
asyomat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Monireh Amerian
Position
Supervisor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Room 409, Third floor, medical School, Shahroud University of Medical Sciences, Hafte-Tir Square, Tehran Avenue, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
0098233234200
Email
amerion@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mostafa Enayatrad
Position
Statistical Advisor
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Room 409, Third floor, medical School, Shahroud University of Medical Sciences, Hafte-Tir Square, Tehran Avenue, Shahroud, Iran.
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5009
Email
mostafaenayatrad@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
Undecided - It is not yet known if there will be 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
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
All collected data will be shared after being unidentified and analyzed
When the data will become available and for how long
2020
To whom data/document is available
For all scholars
Under which criteria data/document could be used
For use in studies
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document
By email and correspondence and justification for use
Comments
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