The aim was to evaluate the effect of folic acid in the treatment of primary enuresis.
Design
This evaluation was a phase 3 clinical trial. Children with diagnosis of primary nocturnal enuresis and approved by a specialist were considered as a study group. In this study, 70 children who met the inclusion criteria were selected. Patients were non-randomly assigned to two groups, 35 children in the folic acid group and 35 children in the control group. Accordingly, treatment lasted 60 days and the frequency of enuresis before and after treatment was recorded.
Settings and conduct
This study will carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria included as children with primary nocturnal enuresis with age higher than 5 years of age, who were willing to participate in the study. Also exclusion criteria included previous nocturnal enuresis and receiving related treatments.
Intervention groups
In the intervention group, in addition to desmopressin spray with a dose of 10 micrograms every night before sleep, folic acid is used at a dose of 1 mg per day for 60 days. Also in control group, desmopressin with a dose of 10 micrograms every night before sleep used along with educating parents and children.
Main outcome variables
Frequency of nocturnal enuresis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013366N14
Registration date:2020-11-06, 1399/08/16
Registration timing:retrospective
Last update:2020-11-06, 1399/08/16
Update count:0
Registration date
2020-11-06, 1399/08/16
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
2019-09-10, 1398/06/19
Expected recruitment end date
2020-05-08, 1399/02/19
Actual recruitment start date
2019-09-10, 1398/06/19
Actual recruitment end date
2020-05-08, 1399/02/19
Trial completion date
2020-05-08, 1399/02/19
Scientific title
Evaluation of the Effect of Folic Acid on the Treatment of Primary Nocturnal Enuresis.
Public title
Evaluation Effect of Folic Acid on Nocturnal Enuresis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with primary enuresis
Age more than 5 years of age
Satisfaction to participate in the study
Exclusion criteria:
History of enuresis
Receive enuresis-related treatments
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
3848176941
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.ARAKMU.REC.1397.314
Health conditions studied
1
Description of health condition studied
Primary nocturnal enuresis
ICD-10 code
N39.44
ICD-10 code description
Nocturnal enuresis
Primary outcomes
1
Description
Frequency of nocturnal enuresis
Timepoint
Before treatment and 2 months after starting treatment
Method of measurement
Based on checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, in addition to desmopressin spray with a dose of 10 micrograms every night before sleep, folic acid is used as a dose of 1 mg per day for 60 days.
Category
Treatment - Drugs
2
Description
Control group: In this group, only desmopressin with a dose of 10 micrograms every night before sleep is used, along with parent and child education.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Masoud Rezagholizamenjany
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arark
Province
Markazi
Postal code
3819693345
Phone
+98 86 3457 3785
Email
masoudrezagholi074@gmail.com
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
Anoushirvani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?