- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01198587
Oral Zinc for the Treatment of Acute Diarrhea in US Children
A Double Blind Randomized Placebo Controlled Trial of Oral Zinc for Children With Acute Diarrhea in a Developed Nation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In developing countries, diarrheal diseases are a leading cause of childhood morbidity and mortality. In the United States an estimated 4.67 million children per year suffer from gastroenteritis with a diarrheal component, impacting the delivery and cost of healthcare. Seventy-five percent of these children are brought to physician care across a range of settings from clinics to emergency departments. Children less than five years of age average 1.3 - 2.5 episodes per year, with 1.4% of those children requiring hospitalization annually. This results in an estimated 209,000 hospitalizations yearly for gastroenteritis. The impact of acute gastrointestinal disease can be felt in the developed world, including the United States, as cost attributed to hospitalization and productivity lost. Attempts at treating gastroenteritis have included Oral Rehydration Solution (ORS), introduced 30 years ago by the WHO, which continues to provide a safe and effective way to maintain hydration during acute illness. ORS, however, does not reduce the volume or frequency of stool output in diarrhea. The anti-diarrheal medication loperamide (Imodium®) was commonly used in children until reports of serious adverse reactions caused its use to fall out of favor. There are no other medications or supplements available to specifically treat the diarrheal component of gastroenteritis and studies have shown that adherence to treatment recommendations regarding fluid therapy is poor because care givers want to reduce duration of illness as opposed to supporting children through the natural course of the disease. The desire to relieve diarrheal symptoms often leads care givers to seek antibiotics during a time of rising antibiotic resistance, as well as other treatments with no proven efficacy.
Zinc is an essential trace element for humans. Its physiologic roles are seen throughout the body as a critical cofactor for enzymatic reactions; most notable are its actions in the gastrointestinal (GI) tract. Zinc is an important component of brush border enzymatic activity which promotes gastrointestinal absorption, it regulates water/electrolyte transport at the cellular level, and it enhances the repair of the intestinal mucosa by bolstering immune function. Over the past 10-15 years, there have been more than a dozen randomized controlled trials of zinc supplementation performed in children living in developing countries that have reported improvements in the duration and severity of diarrhea when compared to placebo in a variety of in- and outpatient settings. The majority of zinc trials were conducted in countries at high risk of zinc deficiency, but those conducted at medium risk showed similar effect on duration and severity. When stratified across all nutritional groups based on serum zinc levels a significant effect was seen compared to placebo despite baseline zinc level, with no occurrence of serious adverse reaction in any group. Given these results, the WHO has endorsed zinc supplementation for all children with acute diarrhea, despite the lack of data from similarly designed studies in industrialized/developed settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Outpatient Zinc Sulfate
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.
Other Names:
|
Experimental: Inpatient Zinc Sulfate
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.
Other Names:
|
Placebo Comparator: Outpatient Placebo
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
Other Names:
|
Placebo Comparator: Inpatient Placebo
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.
Time Frame: 14 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents
Time Frame: over the 14 day symptom monitoring period
|
over the 14 day symptom monitoring period
|
|
Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.
Time Frame: agreement over the 14 day follow up period
|
Kappa inter-rater reliability measurement was done to analyze the agreement between the phone call data with parents reporting the number of episodes of diarrhea per day were compared to the written symptom charts where parents recorded the number of episodes of diarrhea per day.
The inter-rater reliability ranges from 0 to 1 with scores of 0-0.2 = poor agreement, 0.2-0.4
= fair agreement, 0.4-0.6 = moderate agreement, 0.6-0.8
= good agreement and 0.8-1 = very good agreement
|
agreement over the 14 day follow up period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-01-0022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroenteritis
-
GlaxoSmithKlineCompletedRotavirus Gastroenteritis | Nosocomial Rotavirus Gastroenteritis
-
University Hospital for Infectious Diseases, CroatiaCompletedRotavirus GastroenteritisCroatia
-
National Institute of Allergy and Infectious Diseases...CompletedGastroenteritis NorovirusUnited States
-
Merck Sharp & Dohme LLCCompleted
-
MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.ParexelCompletedRotavirus GastroenteritisBangladesh
-
PATHCenters for Disease Control and Prevention; Noguchi Memorial Institute for... and other collaboratorsCompletedRotavirus GastroenteritisGhana
-
GlaxoSmithKlineCompletedRotavirus GastroenteritisGreece
-
Shantha Biotechnics LimitedCompletedRotavirus GastroenteritisIndia
-
Shantha Biotechnics LimitedUnknownRotavirus GastroenteritisIndia
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on Zinc Sulfate
-
International Centre for Diarrhoeal Disease Research...Completed
-
Instituto Nacional de Salud Publica, MexicoUNICEFCompletedDiarrhea, Infantile | Diarrhoea;AcuteMexico
-
Hormozgan University of Medical SciencesCompleted
-
University of VermontNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting
-
Babylon UniversityMinistry of Health, IraqCompletedAsthenozoospermiaIraq
-
mahmoud hussein hadwanMinistry of Health, IraqCompleted
-
Mansoura UniversityCompleted
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedGastric Carcinoma | Unresectable Pancreatic Carcinoma | Liver and Intrahepatic Bile Duct Carcinoma | Unresectable Esophageal CarcinomaUnited States
-
Universidad Nacional Autonoma de MexicoHospital General de Mexico; Hospital Pediatrico de CoyoacanCompletedPneumonia | Children, OnlyMexico
-
UCSF Benioff Children's Hospital OaklandChildren's Hospital Medical Center, CincinnatiCompletedCritical IllnessUnited States