Objectives: Primary nocturnal enuresis is one of the most common and important problems in school-aged children. This disorder can induce problems range from behavioral problems, psychosocial for the child.
Design: This study is a clinical trial that performed on children 5-12 years old and suffering from nocturnal enuresis (Involuntary excretion of urine at night more than 2 times per week for 3 months in children over 5 years is considered to be nocturnal enuresis), referring to Amir Kabir Hospital.
Setting and conduct: In this study, all the patients after obtaining informed consent, give a specific food recipes as well as Desmopressin spray will starts for disease, inaddition said to parents that since the visit for a month in addition to the use of desmopressin spray, follow the recommended diet and record the number of nocturnal enuresis during these two months in a questionnaire which have placed for them. At the end the data were evaluated.
Participants including major eligibility criteria: 180 children with primary nocturnal enuresis according to DSM-IV-TR criteria, without any underlying problem and do not have any chronic diseases were enrolled to study, and patients who refuse to cooperate were excluded.
Intervention: Nutritional status evaluation and offering nutritional program.
main outcome measures (variables): Nutritional status.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051213366N7
Registration date:2017-05-31, 1396/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
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
Arak University of Medical Sciences
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nutritional Factors in the Treatment of Primary Nocturnal Enuresis in Children
Public title
The Effect of Nutrition in the Treatment of Enuresis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all children with primary nocturnal enuresis based on the criteria of DSM-IV-TR؛ without any underlying problem as secondary enuresis؛ did not have a chronic disease؛ did not chronic consumption of any drugs.
Exclusion criteria: Patients who are not willing to cooperate in the completing questionnaires؛ in the middle of the projects lake of their cooperation.
Age
From 5 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Arak University of Medical Sciences
Street address
3848176941,Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Postal code
Approval date
2016-10-17, 1395/07/26
Ethics committee reference number
IR.ARAKMU.REC.1395.274
Health conditions studied
1
Description of health condition studied
Nocturnal Enuresis
ICD-10 code
F98.0
ICD-10 code description
A disorder characterized by involuntary voiding of urine at night.
Primary outcomes
1
Description
Nocturnal Enuresis
Timepoint
Since intervention for two months
Method of measurement
questionnaire filling
Secondary outcomes
empty
Intervention groups
1
Description
Follow the recommended diet. It is recommended that patients during the day consume vegetables, dried fruits, cereals and eggs. During the evening not consume yogurt, fruit juice, milk and cheese and reduce use of salt, chocolate, soft drinks, tea and juices.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Parsa Yousefichaijan
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
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
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
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