Diarrhea | Oral Zinc for the Treatment of Acute Diarrhea in US Children
Diarrhea research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - Major congenital Heart Disease (any disease where child's baseline oxygen saturations <93%) - Short Gut - Liver disease - History of bowel resection
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zinc SulfateFor 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 capsuleEffervescent oral capsules with similar taste to treatment drug Zinc Sulfate is provided to each patient randomized to the placebo arms of the study
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Outpatient Zinc SulfateZinc Sulfate
Inpatient Zinc SulfateZinc Sulfate
Outpatient PlaceboPlacebo oral capsule
Inpatient PlaceboPlacebo oral capsule
Start Date: November 2010
Completed Date: June 2015
Primary Outcome: Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.
Secondary Outcome: Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents
Study sponsors, principal investigator, and references
Principal Investigator: Michelle L Niescierenko, MD
Lead Sponsor: Boston Children’s Hospital