Protocol summary

Summary
This study is a blinded clinical trial.This study will be conducted on 90 children with acute watery diarrhea, which in 1395 referred to gastrointestinal clinic Amirkola Children’s Hospital(Babol University of Medical Sciences). Children randomly (simple) are divided into two groups: The first group,45 patients receive syrup zinc sulfat(daily20mg) and lactose restricted diet (continued breastfeeding along with the elimination of lactose from the diet, especially the elimination of milk and the use of lactose-free supplement). The second group,45 patients received syrup zinc sulfat(daily20mg) and breast milk with normal diet. Inclusion criteria:children 6 months to 2 years with acute watery diarrhea(i.e.3 or more stools per day for less than 72 h). Exclusion criteria:children under 6 months and more than two years, blood in the stool (dysentery infectious and non-infectious), more than 3 days have passed since the onset of diarrhea, recent use of antibiotics, organic diseases (heart, kidney, etc. .) is known, severe malnutrition (weight for age <60% and/or weight for height <70%), Where diarrhea is causing complications such as seizures and ileus.All patients treated for 2 weeks and will be followed up and the number of defication, Presence or absence of Watery stools and Time to recover watery stools this information will be asked by phon from child mother and Will be recorded in a questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016031326973N1
Registration date: 2016-03-13, 1394/12/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Sanaz Mehrabani
Name of organization / entity
Babol University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
s.mehrabani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research- Babol University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lactose restricted diet in the treatment of pediatric acute diarrhea treated with zinc
Public title
Effect of lactose restricted diet in the treatment of pediatric acute diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:children 6 months to 2 years with acute watery diarrhea(i.e.3 or more stools per day for less than 72 h) Exclusion criteria:children under 6 months and more than two years, blood in the stool (dysentery infectious and non-infectious), more than 3 days have passed since the onset of diarrhea, recent use of antibiotics, organic diseases (heart, kidney, etc. .) is known, severe malnutrition (weight for age <60% and/or weight for height <70%), Where diarrhea is causing complications such as seizures and ileus.
Age
From 6 months old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
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
Babol University of Medical Sciences
Street address
Babol-Ganj afrooz Street-Babol University of Medical Sciences,Department of TResearch and Technology Babol
City
Babol
Postal code
4717641367
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
mubabol.HRI.REC.1394.6

Health conditions studied

1

Description of health condition studied
acute diarrhea
ICD-10 code
A00,A01,A0
ICD-10 code description
Intestinal infectious diseases

Primary outcomes

1

Description
The number of defication per day
Timepoint
Before the intervention, the duration of intervention for 14 days, at the end of intervention
Method of measurement
Improve the diarrhea is defined as the number of bowel movements fewer than three times in 24 hours

Secondary outcomes

1

Description
There are possible side effects of the drug and lactose-free supplement
Timepoint
During the study period and at the end of the study
Method of measurement
according to patiants

Intervention groups

1

Description
Intervention Group: zinc sulfat syrup(daily 20mg) and lactose restricted diet (continued breastfeeding along with the elimination of lactose from the diet, especially the elimination of milk and the use of lactose-free supplement). Zinc sulfate syrup 5 mg / 5ml, 20mg daily for 14 days and GASTRO_FIX(Product by behdashtkar company) as lactos free supplement for children 6_12 month: 7 Cup flat head dissolved in the 210ml boild water(5 times in 24 hours).For children one year and more: 8 Cup flat head dissolved in the 240ml boild water(5 times in 24 hours). GASTRO_FIX Used for 14 days. control Group: zinc sulfat syrup(daily 20mg) and breast milk with normal diet. Zinc sulfate syrup 5 mg / 5ml, 20mg daily for 14 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Hospital Decedent Shafi'zadeh Amirkola
Full name of responsible person
Sanaz Mehrabani (Pediatric gastroenterologist)
Street address
Babol-Amirkola-Children's Hospital Decedent Shafi'zadeh Amirkola
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research- Babol University of Medical Sciences
Full name of responsible person
Hadi Parsian(Research Assistant)
Street address
Babol- Ganj Afrooze Street- University of Medical Sciences- Vice Chancellor for research
City
Babol
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- Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sanaz Mehrabani
Position
Pediatric gastroenterologist/Assistant Professor Babol University of Medical Sciences
Other areas of specialty/work
Street address
Babol - Ganj afrooz street - University of Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
s.mehrabani@mubabol.ac.ir , mehrabanisanaz@yahoo.com , tarahomir@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sanaz Mehrabani
Position
Pediatric gastroenterologist/Assistant Professor Babol University of Medical Sciences
Other areas of specialty/work
Street address
Babol- Gang afrooz Street- University of Medical Sciences- Vice Chancellor for research
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
s.mehrabani@mubabol.ac.ir , tarahomir@gmail.com , mehrabanisanaz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University Medical Sciences
Full name of responsible person
Reza Tarahomi
Position
Medical Student
Other areas of specialty/work
Street address
Babol - Ganj Afrooz Street - University Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
tarahomir@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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