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Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea

NCT01025583 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2010-01-13

No results posted yet for this study

Summary

Hypotonic oral rehydration solutions (ORS) containing zinc and/or prebiotics have been proposed for the treatment of pediatric acute diarrhea but conclusive clinical data about their effect are scanty, especially for children living in developed countries. The investigators aim to evaluate the efficacy of a new hypotonic ORS containing zinc and prebiotics in children with acute diarrhea.

Conditions

Interventions

DIETARY_SUPPLEMENT

hypotonic oral rehydration solution

30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.

DIETARY_SUPPLEMENT

Hypotonic oral rehydration solution with Zn and prebiotics

30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Roberto Berni Canani, MD, PhD · Department of Pediatrics, University Federico II of Naples Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-01-31
Completion
2008-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01025583 on ClinicalTrials.gov