Status:
COMPLETED
Oral Zinc for the Treatment of Acute Diarrhea in US Children
Lead Sponsor:
Boston Children's Hospital
Conditions:
Diarrhea
Gastroenteritis
Eligibility:
All Genders
6-6 years
Phase:
NA
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01198587
Start Date
November 1 2010
End Date
June 1 2015
Last Update
August 22 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115