The effect of 8 weeks versus 12 weeks steroid therapy on serum 25-hydroxy vitamin D level in children with nephrotic syndrome during remission phase: a randomized clinical trial
Objectives: To compare the efficacy of 8 weeks versus 12 weeks steroid therapy on serum 25-hydroxy vitamin D level in children with nephrotic syndrome during remission phase
Design: A randomized clinical trial.
Setting and conduct: All eligible patients with nephrotic syndrome who will refer to clinic of pediatrics during the study period will be enrolled in to the trial.
Inclusion criteria: (a) age of 1-18 years; (b) affected with nephrotic syndrome; (c) being in remission phase.
Exclusion criteria: (a) children with malnutrition; (b) receiving vitamin D supplement during the last three months; (c) having liver, pancreatic, or gastrointestinal diseases; (d) using phenytoin, phenobarbital, isoniazid, or rifampin.
Intervention: oral prednisolone 60 mg/square meter daily for 6 weeks and then oral prednisolone 40 mg/square meter every other day for 6 weeks (totally 12 weeks).
Control: oral prednisolone 60 mg/square meter daily for 4 weeks and then oral prednisolone 40 mg/square meter every other day for 4 weeks (totally 8 weeks).
Primary outcome: measuring the serum 25-hydroxy vitamin D level at the end of treatment through taking blood sample.
Secondary outcome: measuring the relapse of nephrotic syndrome at the end of treatment through taking urine sample and measuring proteinuria equal to or greater than 2 plus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404269014N33
Registration date:2014-05-03, 1393/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks versus 12 weeks steroid therapy on serum 25-hydroxy vitamin D level in children with nephrotic syndrome during remission phase: a randomized clinical trial
Public title
The effect of 8 weeks versus 12 weeks steroid therapy on serum 25-hydroxy vitamin D level in children with nephrotic syndrome during remission phase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 1-18 years; (b) affected with nephrotic syndrome; (c) being in remission phase.
Exclusion criteria: (a) children with malnutrition; (b) receiving vitamin D supplement during the last three months; (c) having liver, pancreatic, or gastrointestinal diseases; (d) using phenytoin, phenobarbital, isoniazid, or rifampin.
Age
From 1 year old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: patients will be divided into two groups according to the time of admission. One group will receive oral prednisolone for 8 weeks and another group will receive oral prednisolone for 12 weeks.
Blinding: since the duration of treatment is different in intervention and control groups, blinding is impossible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
D/P/16/35/9/2932
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
the serum 25-hydroxy vitamin D level
Timepoint
at the end of treatment
Method of measurement
through taking blood sample
Secondary outcomes
1
Description
measuring the relapse of nephrotic syndrome
Timepoint
at the end of treatment
Method of measurement
through taking urine sample and measuring proteinuria equal to or greater than 2 plus
Intervention groups
1
Description
oral prednisolone 60 mg/square meter daily for 6 weeks and then oral prednisolone 40 mg/square meter every other day for 6 weeks (totally 12 weeks).
Category
Treatment - Drugs
2
Description
oral prednisolone 60 mg/square meter daily for 4 weeks and then oral prednisolone 40 mg/square meter every other day for 4 weeks (totally 8 weeks).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Dr Aminosadat Sharif
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Beasat Hospital
Full name of responsible person
Dr Aminosadat Sharif
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Postal code
Phone
+98 81 1264 0040
Fax
Email
amin.sharif63@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beasat Hospital
Full name of responsible person
Dr Hossein Emad Momtaz
Position
Pediatrician
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Postal code
Phone
+98 81 1264 0040
Fax
Email
hemmtz@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)