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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01269892
First received: January 3, 2011
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Acute Diarrhea
Dietary Supplement: lactose-free milk
Dietary Supplement: conventional milk
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of Nutritional Regime for Acute Diarrhea

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • duration of diarrhea [ Time Frame: at seven days after admission ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at seven days after admission ] [ Designated as safety issue: Yes ]
    nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission


Enrollment: 74
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 14 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269892

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

Additional Information:
No publications provided

Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01269892     History of Changes
Other Study ID Numbers: ASD-1213-9
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
diarrhea, lactose, milk, weight, acute.

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 29, 2014