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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.

Condition or disease Intervention/treatment Phase
Acute Diarrhea Dietary Supplement: lactose-free milk Dietary Supplement: conventional milk Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of Nutritional Regime for Acute Diarrhea
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
lactose-free milk
it is kind of nutritional regime
Dietary Supplement: lactose-free milk
a milk without lactose
Other Name: nothing

conventional milk
it is kind of nutritional regime
Dietary Supplement: conventional milk
a milk with lactose
Other Name: nothing




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Months to 14 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269892


Locations
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Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Chair: Ali Gholamrezaei, MD MD,research comittee

Additional Information:
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Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01269892    
Other Study ID Numbers: ASD-1213-9
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2009
Keywords provided by Isfahan University of Medical Sciences:
diarrhea, lactose, milk, weight, acute.
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms