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NCT01198587 · ClinicalTrials.gov registry record · NA

Oral Zinc for the Treatment of Acute Diarrhea in US Children

A NA study, sponsored by Boston Children's Hospital.

Completed
Registry status
NA
Development phase
71
Enrollment target

NCT01198587 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 71 participants.

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The verdict

NCT01198587, a NA study, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
NA
Development phase
71 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo oral capsule
  • DRUG Zinc Sulfate

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2010-11
Est. Completion 2015-06
Phase NA

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT01198587

The ClinicalTrials.gov registry entry for NCT01198587 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.

NCT01198587 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01198587 about?

NCT01198587 is a clinical study titled "Oral Zinc for the Treatment of Acute Diarrhea in US Children". 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 s...

What is the current status of trial NCT01198587?

This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2010-11. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01198587?

The interventions under investigation include: Placebo oral capsule (DRUG), Zinc Sulfate (DRUG).

Who is sponsoring clinical trial NCT01198587?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.