Oral Zinc for the Treatment of Acute Diarrhea in US Children

NCT01198587 | Completed Results DMC

• 1 other identifier: 10-01-0022
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Diarrhea; Gastroenteritis

Keywords

Diarrhea; Gastroenteritis; Zinc Supplementation

Outcome Measures

Primary Outcomes (1)

• Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.

  Patients symptoms will be assessed to identify the duration of diarrhea between zinc and placebo groups before it becomes chronic diarrhea which by definition lasts longer than 14 days. Outcome of all patients in study will be assessed at study conclusion.

  14 days

Secondary Outcomes (2)

• Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents

  over the 14 day symptom monitoring period

• Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.

  agreement over the 14 day follow up period

Study Arms (4)

Outpatient Zinc Sulfate

EXPERIMENTAL

Zinc Sulfate

Drug: Zinc Sulfate

Inpatient Zinc Sulfate

EXPERIMENTAL

Zinc Sulfate

Drug: Zinc Sulfate

Outpatient Placebo

PLACEBO COMPARATOR

Placebo oral capsule

Drug: Placebo oral capsule

Inpatient Placebo

PLACEBO COMPARATOR

Placebo oral capsule

Drug: Placebo oral capsule

Interventions

Zinc Sulfate DRUG

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.

Also known as: Treatment

Inpatient Zinc Sulfate; Outpatient Zinc Sulfate

Placebo oral capsule DRUG

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

Also known as: Placebo

Inpatient Placebo; Outpatient Placebo

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Children with non-bloody diarrhea illness defined as loose or watery stools
• Symptoms must be present for greater than 24 hours but less than 72 hours.
• Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs, Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy (unless developmentally delayed), Children born Prematurely between 33-37 weeks without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for \>6 months), Diabetes may be enrolled in the study.

You may not qualify if:

• Children with symptoms less than 24 hours
• Children with symptoms greater than 24 hours
• Failure to thrive
• G or J tube
• Major surgery within last 3 months
• Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month
• Followed by GI service for any reason (crohns, ulcerative colitis, constipation)
• Developmental delay, patient \>1 year behind milestones
• Current brain tumor
• Currently being treated for cancer or in remission \< 6 months
• Intussuception
• Antibiotics in the last 14 days or currently taking antibiotics for any reason
• Autism
• Children born premature \<33 weeks
• Cystic Fibrosis

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diarrhea; Gastroenteritis

Interventions

Zinc Sulfate; Therapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Results Point of Contact

• Title: Michelle Niescierenko MD MPH
• Organization: Boston Children's Hospital

michelle.niescierenko@childrens.harvard.edu

617-919-4121

Study Officials

• Michelle L Niescierenko, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Richard Bachur, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Christopher Duggan, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow Emergency Medicine

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 10, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2018-08

Locations

US (1)