Vomiting due to gastroenteritis can cause some complications. Various drugs used for treatment of vomiting. In pediatrics there is no evidence for treatment of vomiting with pyridoxine. This study reviews the effect of pyridoxine in treatment of acute gastroenteritis in children. This study is single blind randomized clinical trial with placebo and single center. Children admitted with gastroenteritis in Amirkabir hospital from August to December 2011 and had inclusion criteria placed in case and control group. Sample size is 140. Control group will treat with parenteral rehydration and placebo (distilled water). Case group will treat with parenteral rehydration and parenteral pyridoxine.
Frequency of vomiting and other symptoms collect with checklist from admission until third day. Response to treatment compares in case and control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108167342N1
Registration date:2012-01-17, 1390/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-17, 1390/10/27
Registrant information
Name
Farshad Jafari
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 5378
Email address
farshadjafari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services
Expected recruitment start date
2011-09-11, 1390/06/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pyridoxine(Vitamin B6) in control of vomiting due to acute gastroenteritis in children 6 month to 12 years
Public title
Effect of Pyridoxine(Vitamin B6) in control of vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.6 month to 12 years old child.
2.Acute viral gastroenteritis with vomiting.
3.No treatment before admission.
4.Completed consent form.
Exclusion criteria:
1.Severe dehydration.
2.Abnormal finding in stool exam (RBC, WBC, parasite).
3.Acute abdomen.
4.Patient withdrew from the project.
5.Discharge the patient with personal satisfaction.
Age
To 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
Vice Chancellor for Research, Arak University of Medical Sciences, Pardis site, Basij Square, Arak, Iran
City
Arak
Postal code
3848176941
Approval date
2011-09-05, 1390/06/14
Ethics committee reference number
90-112-4
Health conditions studied
1
Description of health condition studied
Vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Frequency of vomiting
Timepoint
8 hour before admition,first day,second day,third day of admition
Method of measurement
Frequency of vomiting with questionnaire
Secondary outcomes
1
Description
dayes of admition
Timepoint
day
Method of measurement
dayes of admition with quetionnaire
Intervention groups
1
Description
Case group: pyridoxine 2mg/kg (max 60 mg) IV, stat, at admission. Frequency of vomiting and days of admission are calculated.
Category
Treatment - Drugs
2
Description
Control group: parenteral rehydration with placebo (1 ml distilled water) IV at admission. Frequency of vomiting and days of admission are calculated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Parsa Yousefi,Farshad Jafari
Street address
Vice Chancellor for Education of AmirKabir Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Said Changizi Ashtiani
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, Pardis site, Basij Square, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences and Health Services research
Full name of responsible person
Parsa Yousefi
Position
Assistant Professor, Pediatrics Nephrologist
Other areas of specialty/work
Street address
Amirkabir Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefi
Position
Assistant Professor, Pediatrics Nephrologist
Other areas of specialty/work
Street address
Amirkabir Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Farshad Jafari
Position
Pediatrics Resident
Other areas of specialty/work
Street address
Amirkabir Hospital
City
Arak
Postal code
Phone
+98 86 1313 5378
Fax
Email
farshadjafari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)