The aim of this study is to evaluate the effectiveness of removal of spices and sweets on reducing night sweats in children. 30 children 18 to 20 months with night sweats, who referred to health centers of Yazd are selected. These children must be healthy and do not have any systemic diseases and drug use. The questionnaires are completed in the first day. The children's parents will be asked to eliminate the sweets and spices from baby food, for two weeks. People who do not comply with the required dietary or may not be willing to cooperate, are excluded. At the end of two weeks, the questionnaires are completed. The severity of night sweats and sleep disturbances are compared before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020516432N1
Registration date:2014-07-09, 1393/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-09, 1393/04/18
Registrant information
Name
Meysam Reza Boghrati
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4737
Email address
boghrati@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Elimination of sweets and spices on night sweats in children, before-after study.
Public title
The Efficacy Of Elimination of Sweets and Spices In Reduction Of Night Sweats In Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy Children 18 To 20 Months; No Systemic Disease; No Congenital Malformations; Not Taking Medication.
Exclusion Criteria: Non-Compliance With Diet; Lack Of Cooperation In The Study; Systemic Diseases; Drug Intake For A Week.
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Buillding of University, Bahonar Square, Yazd
City
Yazd
Postal code
Approval date
2014-03-18, 1392/12/27
Ethics committee reference number
257428/1/17/پ
Health conditions studied
1
Description of health condition studied
Night Sweats
ICD-10 code
R61.9
ICD-10 code description
Hyperhidrosis, unspecified Excessive sweating Night sweats
Primary outcomes
1
Description
Night Sweats
Timepoint
The First Day Before The Intervention, Two Weeks After The Intervention
Method of measurement
Night Sweats Questionnaire
Secondary outcomes
1
Description
Sleep Disorders
Timepoint
The First Day Before The Intervention, Two Weeks After The Intervention
Method of measurement
Standard Questionnaire For Sleep Disorders
Intervention groups
1
Description
Remove of Sweets and Spices From Child`s Diet For Two Weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Rahmat Abad Health Center
Full name of responsible person
Dr. Rashidpour
Street address
Rahmat Abad Health Center, Dashti Boulevard, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Fatemah Ezoddini
Street address
Deputy for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University Of Medical Sciences
Full name of responsible person
Meysam Reza Boghrati
Position
Pediatric Resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Reyazi Sq, Safaeye
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
boghrati@ssu.ac.irmeysam_reza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences
Full name of responsible person
Meysam Reza Boghrati
Position
Pediatric Resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Reyazi Sq, Safaeye
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
boghrati@ssu.ac.ir meysam_reza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University Of Medical Sciences
Full name of responsible person
Meysam Reza Boghrati
Position
Pediatric Resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Reyazi Sq, Safaeye
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
boghrati@ssu.ac.ir meysam_reza@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)