Protocol summary

Study aim
The Effect of Vitamin D on Nephrotic Syndrome in Children
Design
This assessment is a clinical trial in Phase 3, children diagnosed with nephrotic syndrome that have been verified by pediatric specialist, are considered as study group. In this study, 60 children who meet the criteria are selected. Patients are categorized based on blocked randomization method, 30 children in the intervention group and 30 children in the control group. Accordingly, at the beginning of the diagnosis and 1 months after the start of treatment, the condition of the nephrotic syndrome is evaluated by signs and symptoms.
Settings and conduct
This study was carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Inclusion criteria is the only Nephrotic Syndrome, while patients who are not available during the next year to refer to the facility for follow-up or have other underlying conditions (such as hematology diseases or any other chronic disease), or intake drug for another illness, were excluded.
Intervention groups
In intervention group, in addition to the usual treatment of nephrotic syndrome (corticosteroid), we also used vitamin D, in which vitamin D is administered as an ampoule of 300,000 units, with a volume of one cc and 5 cc of olive oil is dissolved and injected, in addition in control group we used the usual treatment for Nephrotic Syndrome is 60 mg / m2 / day is 60 mg of prednisolone (maximum dose of 80 mg / m2 / day) for 4-6 weeks, which is used in the control group.
Main outcome variables
Signs of Nephrotic Syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130518013366N11
Registration date: 2019-03-11, 1397/12/20
Registration timing: prospective

Last update: 2019-03-11, 1397/12/20
Update count: 0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-05, 1398/01/16
Expected recruitment end date
2019-10-08, 1398/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin D on Nephrotic Syndrome in Children
Public title
Vitamin D in Nephrotic Syndrome in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Affected to Nephrotic Syndrome
Exclusion criteria:
Patients who were not available during the next year and can not go to the center for follow-up treatment Patients with other underlying illnesses
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, Accordingly, the patients under study are divided into two groups. The allocation of patients in two groups was based on demographic characteristics and their matching. Based on this, after considering the patients' demographic data, patients were divided into two equal groups of patients, they enrolled in the study and performed desired intervention on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.ARAKMU.REC.1397.271

Health conditions studied

1

Description of health condition studied
Nephrotic Syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome

Primary outcomes

1

Description
Signs of Nephrotic Syndrome
Timepoint
Before treatment and 2 months after the administration of vitamin D
Method of measurement
Urine and blood test and clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In these patients, in addition to the usual treatment of nephrotic syndrome (corticosteroid), we also used vitamin D, in which vitamin D is administered as an ampoule of 300,000 units, with a volume of one cc and 5 cc of olive oil is dissolved and injected.
Category
Treatment - Drugs

2

Description
Control group: The usual treatment for Nephrotic Syndrome is 60 mg / m2 / day is 60 mg of prednisolone (maximum dose of 80 mg / m2 / day) for 4-6 weeks, which is used in the control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Shahriar Hasanzadeh
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
shahriarhasanzadeh@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
arashanoushirvani@gmail.com
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
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
Arak University of Medical Sciences
Full name of responsible person
Shahriar Hasanzadeh
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatric
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
shahriarhasanzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefichaijan
Position
Associate Professor of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
parsayousefichaijan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hasan Taherahmadi
Position
Assistant Professor of Pediatric Diseases
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
hasantaherahmadi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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