Aim will evaluation effect of vitamin B complex in the treatment of primary nocturnal enuresis.
Design
This evaluation is a phase 3 clinical trial. Children with diagnosis of primary nocturnal enuresis and approved by a specialist will considered as a study group. In this study, 70 children who met the inclusion criteria will selected. Patients will non-randomly assigned to two groups, 35 children in the B complex vitamin group and 35 children in the control group. Accordingly, treatment lasted 60 days and the frequency of enuresis before and after treatment will 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, B complex vitamin will used at a dose of 1 tablet 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:IRCT20201028049172N1
Registration date:2021-11-16, 1400/08/25
Registration timing:registered_while_recruiting
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Sahar Alimoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4222 6774
Email address
sahar.alimoradi70.sa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of vitamin B complex in the treatment of primary nocturnal enuresis
Public title
Evaluation of the effect of vitamin B complex 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
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
2021-09-21, 1400/06/30
Ethics committee reference number
IR.ARAKMU.REC.1400.142
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, B complex tablet is used as a dose of 1 tab 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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Sahar Alimoradi
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3321 4418
Email
saharalimoradi@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?