The comparison of oral calcium effect in addition to conventional treatment in duration of diarrhea with convention treatment alone in children admitted due to acute gastroenteritis
(1) Objectives:The evaluation oral calcium effect in addition to conventional treatment in duration of diarrhea in children admitted in hospital due to acute gastroenteritis. (2)Design: In this single blind randomized clinical trial we have studied patients one month to 12 years old with acute and noninflamatory diarrhea who had needed to admit in hospital for receiving intravenous therapy (inclusion criteria) .The patients who had inflammatory diarrhea; chronic or secondary diarrhea; and those who primarily had serum calcium out of normal level, were excluded from our study (exclution criteria). Finally, 124 patients divided randomizely to two groups of 62 . The control group received conventional treatment including serum therapy and correcting electrolytic and acid base derangements. The intervention group received calcium complement as calcium gluconate 10% , o.5cc/kg in 3 divided dose per day as open lable administeration in addition to conventional therapy. The duration, times and volume of diarrhea (primary outcome), and adverse effects appeard during treatment (secondary outcome), and other variables were compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110624900N1
Registration date:2017-01-25, 1395/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Mojgan Amrolalaie
Name of organization / entity
Iran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 2041
Email address
sayyahfar.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of oral calcium effect in addition to conventional treatment in duration of diarrhea with convention treatment alone in children admitted due to acute gastroenteritis
Public title
Evaluation of calcium effect in Children Gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclution Criteria: Patients one month to 12 years of age with acute and noninflamatory diarrhea who had needed to admit in hospital for receiving intravenous therapy
Exclution Criteria: The patients who had chronic diarrhea; or secondary diarrhea(due to sepsis , uti, drugs, endocrine or metabolic); those who primarily had serum calcium out of normal level; and those who gave up contribution, excluded from our study
Age
From 1 year old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
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
Iran University of Medical Sciense
Street address
Hemmat Highway
City
Tehran
Postal code
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
1790
Health conditions studied
1
Description of health condition studied
Acute Gastroenteritis
ICD-10 code
A09.0
ICD-10 code description
other and unspecified gastroenteritis and colitis of infectious origin
Primary outcomes
1
Description
duration, intensity and volume of diarrhea
Timepoint
days of 1, 3, 7 after treatment
Method of measurement
duration of diarrhea, times, and volume of stool (mother assesment)
Secondary outcomes
1
Description
Adverse effects of treatment including nausia, vomitting, abdominal pain, constipation
Timepoint
days of 1, 3 ,7 after treatment
Method of measurement
patient visit, question from nurse or mother
Intervention groups
1
Description
Intervention group: Administeration of gluconate calcium 10%, 0.5 ml/kg/day in 3 divided doses for 3 days in addition to conventional treatment including rehydration, correcting electerlites and acid base derangements
Category
Treatment - Drugs
2
Description
Control group: Conventional therapy including rehydration, correcting electerolites and acid and base derangements
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Hazrat Aliasghar Children Hospital
Full name of responsible person
Dr Mojgan Amrolalaie
Street address
Zafar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Science/Hazrat Aliasghar Hospital
Full name of responsible person
Dr Mojgan Amrolalaie
Street address
Zafar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science/Hazrat Aliasghar Hospital
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
Iran University of Medical Sciense
Full name of responsible person
Dr Mojgan Amrolalaie
Position
Pediatric Subspeciality Resident
Other areas of specialty/work
Street address
Zafar Street
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
+98 21 2222 2063
Email
dr.alaeii@gmail.com; sayyahfar.sh@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciense
Full name of responsible person
Dr Shirin Sayyahfar
Position
Assistant Professor, Subspecialist of Pediatric Infectious Diseases
Other areas of specialty/work
Street address
Zafar Street
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
+98 21 2222 2063
Email
sayyahfar.sh@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciense
Full name of responsible person
Dr Mojgan Amrolalaie
Position
Pediatric Subspeciality Resident
Other areas of specialty/work
Street address
Hazrat Aliasghar Hospital, Zafar Street
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
+98 21 2222 2063
Email
dr.alaeii@gmail.com; sayyahfar.sh@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)