Objectives: evaluating therapeutic effects of active form of vitamin D on acute kidney injury (AKI) improvement. Inclusion criteria: AKI patients aged 18 or more; voluntary participation in the study; admission in ordinary ward, CCU or ICU. exclusion criteria: using vitamin D or its derivatives or having serum Ca level more than 10.5 mg/dl at the beginning of study ; any type of malignancy leading to serum Ca more than 10.5 mg/dl. design: a single blind study (for patients only) on 122 AKI cases in two hospitals who were randomly divided in to two groups including 61 patients each by block A and B method, matched for age, sex, AKI type and severity .setting and conduct and intervention: intervention group patients received 0.25 mg/day calcitriol at the time of AKI diagnosis up to recovery or for three months if recovery did not occur. Control group received placebo as a capsule filled with starch daily since AKI diagnosis up to recovery or for three months if recovery did not happen. BUN and creatinine were checked daily during admission, then weekly for the first month since diagnosis and monthly for 3 months thereafter. after 3 months, recovery time, admission duration, dialysis sessions and maximum creatinine level during admission, frequency of developing chronic kidney disease (CKD) and mortality rate were compared between two groups as primary outcome measures. plasma calcium and phosphorus level were compared at the beginning and at the end of intervention between two groups as secondary outcome measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022326716N1
Registration date:2016-07-30, 1395/05/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Mehrak Montazeran
Name of organization / entity
University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3471 3630
Email address
m.montazeran@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Calcitriol treatment on acute kidney injury improvement
Public title
Evaluation of the effects of Calcitriol on acute kidney injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age:18 years old or more; voluntary participation in the study؛.admission in ordinary wards, CCU, ICU
Exclusion criteria:
Using vitamin D or its derivatives at the time of study initiation;the type of malignancies that lead to calcium level more than 10.5mg/dl;serum calcium level more than 10.5mg/dl
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Arak University of Medical Sciences
Street address
Arak
City
Arak
Postal code
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
93-176-29
Health conditions studied
1
Description of health condition studied
acute kidney injury
ICD-10 code
n17.0
ICD-10 code description
acute renal impairment
Primary outcomes
1
Description
maximum creatinin level
Timepoint
daily
Method of measurement
blood sampling
2
Description
number of dialysis sessions during admission
Timepoint
daily
Method of measurement
researcher made checklist
3
Description
admission duration
Timepoint
daily
Method of measurement
researcher made checklist
4
Description
recovery duration
Timepoint
daily
Method of measurement
researcher made checklist
5
Description
becoming CKD
Timepoint
monthly up to three months
Method of measurement
serum creatinin measurement
6
Description
mortality rate
Timepoint
three months maximum
Method of measurement
researcher made checklist
Secondary outcomes
1
Description
hyperphosphatemia
Timepoint
during three months
Method of measurement
blood sampling
2
Description
hypercalcemia
Timepoint
during three months
Method of measurement
blood sampling
Intervention groups
1
Description
0.25 mg of calcitriol was given to the patients in intervention group on a daily basis since AKI diagnosis up to recovery or for 3 months since the diagnosis of AKI if recovery did not happen
Category
Treatment - Drugs
2
Description
One capsule filled with starch was given to the patients in control group on a daily basis since AKI diagnosis up to recovery or for 3 months since the diagnosis of AKI if recovery did not happen
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Almomnin Hospital
Full name of responsible person
Street address
City
Arak
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 Rafie
Street address
Arak,Sardasht, University of Medical Sciences
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
ARAK University of Medical Sciences
Full name of responsible person
Mehrak Montazeran
Position
Resident
Other areas of specialty/work
Street address
ARAK University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3630
Fax
Email
m.montazeran@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ARAK University of Medical Sciences
Full name of responsible person
Dr Mehrak Montazeran
Position
Resident
Other areas of specialty/work
Street address
Hospital Amiralmomini
City
Arak
Postal code
Phone
+98 86 3417 3630
Fax
Email
mehrak_mtn@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak Medical University
Full name of responsible person
Mehrak Montazeran
Position
Iinternal Medicine Resident
Other areas of specialty/work
Street address
Number 69, Rezvan alley, shahid Rajaii street,Arak,
City
Arak
Postal code
3813914574
Phone
+98 86 3224 3365
Fax
Email
mehrak_mtn@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)