Comparison of the effect of oral vitamin D and probiotics on acute non-inflammatory diarrhea in children 6 months to 6 years
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 186 patients. For randomization, three cards with letters A, B and C are placed in front of the patient and the patient selects one. Each letter belongs to one of three groups used
Settings and conduct
Sealed coded packages are provided to the resident and design partner to provide the drug to the patient based on the code and provide the necessary explanations to the mothers.
Participants/Inclusion and exclusion criteria
Admission criteria: Age 1 to 5 years with acute watery diarrhea. Exclusion criteria: fever above 38.5; severe dehydration; severe diarrhea; severe malnutrition; recent use of antibiotics or antidiarrheal drug; having another complaint in addition to watery diarrhea with immunodeficiency.
Intervention groups
Intervention group 1: The group under one year of age should take 5 drops of paddy lactate 5 drops every 8 hours and 1 to 2 years of Kidi Lactate powder 1/2 cup every 12 hours and over 2 years 1 pint every 12 hours. Intervention group 2: Vitamin D3 supplement group in the form of 800 units of 20 mg daily can be placed under two years due to 400 units of vitamin D drops in 400 units and over 2 years of dose 800 units of vitamin D3 to this group. 7 days control: This group is only allowed as a control group
Main outcome variables
Stool consistency; number of stools; duration of diarrhea; fever, anorexia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210615051584N1
Registration date:2021-07-04, 1400/04/13
Registration timing:registered_while_recruiting
Last update:2021-07-04, 1400/04/13
Update count:0
Registration date
2021-07-04, 1400/04/13
Registrant information
Name
Manige Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
ahmadi.ma@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-17, 1400/03/27
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of oral vitamin D and probiotics on acute non-inflammatory diarrhea in children 6 months to 6 years
Public title
The effect of probiotics and vitamin D on diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute acute watery diarrhea
Exclusion criteria:
Fever above 38.5 degree Centigrade
Severe dehydration
Severe diarrhea
Severe malnutrition
Recent use of antibiotics or antidiarrheal drug
Having another complaint in addition to watery diarrhea with immunodeficiency
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
186
Randomization (investigator's opinion)
Randomized
Randomization description
Three cards with the letters A, B and C are placed in front of the patient and the patient chooses one. Each letter belongs to one of three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the evaluating physician are unaware of the study groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani St.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818863472
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.SKUMS.REC.1399.102
Health conditions studied
1
Description of health condition studied
Acute watery diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Number of times diarrhea
Timepoint
Daily to 7 Day
Method of measurement
Question from the sick mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: the group under one year of age should take 5 drops of paddy lactate 5 drops every 8 hours and 1 to 2 years of Kidi Lactate powder 1/2 cup every 12 hours and over 2 years 1 pint every 12 hours.Intervention group 2: Vitamin D3 supplement group in the form of drops of 800 units of 20 mg daily can be under two years due to 400 units of vitamin D drops in the case of 400 units and over 2 years of 800 units of oral vitamin D3 for 7 days
Category
Treatment - Drugs
2
Description
Control group: this group receives only placebo as a control group for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Dr. Ali Asghar Rabiee
Street address
Hajar Hospital Nurse Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
a.rabiei@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani St. Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3334 2414
Email
mehr.sadeghi1ir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Manigeh Ahmadi
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Nurse Street
City
شهرکرد
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
ahmadi.ma@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Aliasghar Rabiei
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hajar Hospital Nurse Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818863472
Phone
+98 38 3222 0016
Email
a.rabiei@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Manigeh Ahmadi
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hajar Hospital Nurse Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
ahmadimanijeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some of the forgotten theory is related to the main message that can be divided.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic institutions
Under which criteria data/document could be used
Researchers who are writing meta-analysis articles
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
After sending the email via academic email and the reason for the need for data, this study will be provided to the researcher within a week.