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

Phase 2

Completed

• Conditions: Acute Diarrhea
• Interventions: Dietary Supplement: lactose-free milk; Dietary Supplement: conventional milk

• Registration Number: NCT01269892
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Last Update Submitted: 2011-01-03
• Study First Posted: 2011-01-04
• Last Update Posted: 2011-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactose-free milk	lactose-free milk	it is kind of nutritional regime
conventional milk	conventional milk	it is kind of nutritional regime

Primary Outcome Measures

Name	Time	Method
duration of diarrhea	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

Name	Time	Method
changes in weight gaining	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

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of