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Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea

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ClinicalTrials.gov Identifier: NCT01269892
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 3, 2011
First Posted Date  ICMJE January 4, 2011
Last Update Posted Date January 4, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
duration of diarrhea [ Time Frame: at seven days after admission ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
changes in weight gaining [ Time Frame: at seven days after admission ]
nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
Official Title  ICMJE Study of Nutritional Regime for Acute Diarrhea
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Diarrhea
Intervention  ICMJE
  • Dietary Supplement: lactose-free milk
    a milk without lactose
    Other Name: nothing
  • Dietary Supplement: conventional milk
    a milk with lactose
    Other Name: nothing
Study Arms  ICMJE
  • lactose-free milk
    it is kind of nutritional regime
    Intervention: Dietary Supplement: lactose-free milk
  • conventional milk
    it is kind of nutritional regime
    Intervention: Dietary Supplement: conventional milk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2011)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. children with acute non-bloody diarrhea (≤ 2 weeks)
  2. mild to moderate dehydration

Exclusion Criteria:

  1. mucous bloody stools
  2. major systemic illness
  3. severe malnutrition (Weight for age <60% and Weight for height <70 %)
  4. history of antibiotics receiving
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 14 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01269892
Other Study ID Numbers  ICMJE ASD-1213-9
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ali Gholamrezaei, MD MD,research comittee
PRS Account Isfahan University of Medical Sciences
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP