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Oral Zinc for the Treatment of Acute Diarrhea in US Children

NCT01198587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2018-08-22

Study results available
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Summary

Diarrheal diseases are the third leading cause of mortality in the world, with nearly 2 million deaths annually among children under age 5 years. Several clinical trials of oral zinc supplementation performed in developing country populations have confirmed this nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health Organization (WHO) has recommended global use of zinc supplementation in all children with diarrhea despite little or no data from trials in industrialized/developed settings. In the United States over 4 million children suffer annually from diarrheal illness. Although mortality is not a significant factor in U.S. cases, 75% of all cases present to medical care resulting in over 200,000 hospitalizations annually for diarrhea. This has significant impact on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549 per inpatient treatment spent on each episode of acute diarrheal illness. The goal of this study is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea in children treated as outpatients and in decreasing the duration of hospitalization in children treated as inpatients in an industrialized country. The results of this study promise to have a substantial impact on the management of a common pediatric health problem, and could conceivably affect direct and indirect healthcare costs to society.

Conditions

Interventions

DRUG

Zinc Sulfate

For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid. For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.

DRUG

Placebo oral capsule

Effervescent oral capsules with similar taste to treatment drug Zinc Sulfate is provided to each patient randomized to the placebo arms of the study

Sponsors & Collaborators

Principal Investigators

  • Michelle L Niescierenko, MD · Boston Children's Hospital

  • Richard Bachur, MD · Boston Children's Hospital

  • Christopher Duggan, MD, MPH · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01198587 on ClinicalTrials.gov