Back to resultsEarly Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
Primary Purpose
Acute Diarrhea
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
lactose-free milk
conventional milk
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Diarrhea focused on measuring diarrhea, lactose, milk, weight, acute.
Eligibility Criteria
Inclusion Criteria:
- children with acute non-bloody diarrhea (≤ 2 weeks)
- mild to moderate dehydration
Exclusion Criteria:
- mucous bloody stools
- major systemic illness
- severe malnutrition (Weight for age <60% and Weight for height <70 %)
- history of antibiotics receiving
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
lactose-free milk
conventional milk
Arm Description
it is kind of nutritional regime
it is kind of nutritional regime
Outcomes
Primary Outcome Measures
duration of diarrhea
Duration of diarrhea corresponded to the time from enrollment to the cessation of diarrhea, which was defined as the passage of the last watery or loose stool before passage of two consecutive formed stools or no stool in a 24-hour period.
Secondary Outcome Measures
changes in weight gaining
nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission
Full Information
NCT ID
NCT01269892
First Posted
January 3, 2011
Last Updated
January 3, 2011
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01269892
Brief Title
Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
Official Title
Study of Nutritional Regime for Acute Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.
Detailed Description
Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea
Keywords
diarrhea, lactose, milk, weight, acute.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lactose-free milk
Arm Type
Other
Arm Description
it is kind of nutritional regime
Arm Title
conventional milk
Arm Type
Other
Arm Description
it is kind of nutritional regime
Intervention Type
Dietary Supplement
Intervention Name(s)
lactose-free milk
Other Intervention Name(s)
nothing
Intervention Description
a milk without lactose
Intervention Type
Dietary Supplement
Intervention Name(s)
conventional milk
Other Intervention Name(s)
nothing
Intervention Description
a milk with lactose
Primary Outcome Measure Information:
Title
duration of diarrhea
Description
Duration of diarrhea corresponded to the time from enrollment to the cessation of diarrhea, which was defined as the passage of the last watery or loose stool before passage of two consecutive formed stools or no stool in a 24-hour period.
Time Frame
at seven days after admission
Secondary Outcome Measure Information:
Title
changes in weight gaining
Description
nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission
Time Frame
at seven days after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children with acute non-bloody diarrhea (≤ 2 weeks)
mild to moderate dehydration
Exclusion Criteria:
mucous bloody stools
major systemic illness
severe malnutrition (Weight for age <60% and Weight for height <70 %)
history of antibiotics receiving
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Gholamrezaei, MD
Organizational Affiliation
MD,research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical sciences
Learn more about this trial
Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
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