A comparison between the simultaneous consumption of Oral Rehydration Solution (ORS) along with rice soup and consuming ORS per se in the treatment of acute diarrhea in 6-24 months old children
Objectives: This study will compare the simultaneous consumption of Oral Rehydration Solution (ORS) along with rice soup and consuming ORS per se in the treatment of acute diarrhea in 6-24 months old children. Methods: This single blind clinical trial research will be carried out on 40 patients with acute watery diarrhea in the age range of 6-24 months. The patients' diarrhea onset should not exceed 72 hours and they will be hospitalized at the "the 22nd of Bahman Hospital" in Gonabad, Iran. We will obtain the parents' written consent for participation of their children. These children will be randomly assigned into two groups using the Table of Random Numbers. To ensure the sample equality in the two groups, we will employ Balanced Blocking Randomization (BBR) method using four cell blocks. The patients do not know to which group they will be assigned (intervention or control group). The patients in control group will receive ORS for treating diarrhea using the dose recommended by the World Health Organization (WHO); and the patients in intervention group, in addition to ORS, will receive 100 cc of rice soup for those who were one year old or higher and 50 cc for those who were less than one year for every time of excretion. The soup will contain 100 g of Iranian rice, 6 g of table salt, and 1.2 liter of distilled water. The blended rice will be boiled over a gas burner with continuous stirring until the final volume reaches 1 L. Exclusion criteria include: severe vomiting along with diarrhea and the parents' unwillingness to continue the study. Information on background variables, frequency of diarrhea, improvement of diarrhea, and laboratory variables will be recorded in the checklists and then the data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310169459N1
Registration date:2014-01-07, 1392/10/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-07, 1392/10/17
Registrant information
Name
Mojtaba Kianmehr
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
kianmehr.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the simultaneous consumption of Oral Rehydration Solution (ORS) along with rice soup and consuming ORS per se in the treatment of acute diarrhea in 6-24 months old children
Public title
The effect of rice soup in treatment of acute diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: •Children between the ages of 6 and 24 months •Underlying disease may not be the cause of diarrhea. •More than 72 hours from the onset of diarrhea is passed. •The amount of serum sodium and potassium ions is in the normal range. •The patient does not consume the foods such as syrup, artificial ingredients, very sweet food, fruit juice, yogurt, butter milk, etc. that increase or decrease the severity of diarrhea. •The patient should continue with the diet. Exclusion criteria: • Regarding medicine, continuing the research is not possible for the patient. •The patient's parents are not willing to continue the investigation. •If the patient abandons the required diet during the dietary intervention. •If there is severe vomiting along with diarrhea.
Age
From 6 years old to 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Gonabad University of Medical Sciences
Street address
Vice chancellor for research, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Approval date
2012-04-10, 1391/01/22
Ethics committee reference number
91/1/4 / ا ک
Health conditions studied
1
Description of health condition studied
Acute Diarrhea
ICD-10 code
K59.1
ICD-10 code description
functional diarrhea
Primary outcomes
1
Description
The use rate of ORS solution
Timepoint
The first 24 hours, the second 24 hours, and the third 24 hours
Method of measurement
Determination of consumed volume by graded container
2
Description
The use rate of intravenous fluids
Timepoint
The first 24 hours, the second 24 hours, and the third 24 hours
Method of measurement
Observation
3
Description
Serum levels of Na and K ions
Timepoint
The onset of hospitalization, before any kind of intervention
Method of measurement
Blood collection and its experimenting with flame photometer
4
Description
Serum levels of Urea
Timepoint
The onset of hospitalization, before any kind of intervention and at the end of intervention, before discharge
Method of measurement
Blood collection and its experimenting through spectrophotometer
Secondary outcomes
1
Description
Hospitalization stay
Timepoint
The end of intervention
Method of measurement
Observation
Intervention groups
1
Description
Intervention 1 in the control group: the patients in this group will receive ORS (produced by Hayan company, Iran) for treating diarrhea using the treatment recommended by WHO based on which the required amount of both intravenous injections and ORS has been determined.
Category
Treatment - Other
2
Description
Intervention 2 in the intervention group: the patients in this group, in addition to ORS (produced by Hayan company, Iran), will receive rice soup till their dismissal from the hospital based on the treatment recommended for diarrhea by WHO. The soup will be 100 cc for those who are one year old or higher and 50 cc for those who are less than one year old for every time of excretion. In this regard, we will decrease the amount of ORS so that it will not exceed the allowed amount received by the patient. The soup will contain 100 g of Iranian rice, 6 g of table salt, and 1.2 liter of distilled water. The blended rice will be boiled over a gas burner with continuous stirring until the final volume reaches 1 L.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
the 22nd of Bahman Hospital, Gonabad University of Medical Sciences
Full name of responsible person
Jalil Moshari
Street address
the 22nd of Bahman Hospital, Naser Khosro St.
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Ali Ekrami
Street address
Vice chancellor for research, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mojtaba Kianmehr
Position
PhD in Biophysics / Assistant Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
kianmehr.m@gmu.ac.ir
Web page address
www.gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Jalil Moshari
Position
Pediatrician / Assistant Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
dr.moshari@gmu.ac.ir; dr.moshari@yahoo.com
Web page address
www.gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mojtaba Kianmehr
Position
PhD in Biophysics / Assistant Professor
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 5027
Fax
+98 53 3722 3814
Email
kianmehr.m@gmu.ac.ir
Web page address
www.gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)