Impact of Home Zinc Treatment for Acute Diarrhea in Children

Status Completed

Clinical Trial Summary

Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied.

Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year.

Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Diarrhea

Clinical Trial Details

NCT number	NCT00530829
Study type	Interventional
Source	Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	Phase 3
Start date	October 2007
Completion date	April 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06283784` - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients	N/A
Recruiting	`NCT03851835` - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis	Phase 3
Completed	`NCT04003181` - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon	N/A
Completed	`NCT03596827` - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection	N/A
Recruiting	`NCT05372068` - Cement flooRs AnD chiLd hEalth (CRADLE)	N/A
Completed	`NCT03972618` - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT05052489` - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed	`NCT02428647` - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation	N/A
Completed	`NCT02541695` - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT01739231` - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults	Phase 1/Phase 2
Completed	`NCT01968408` - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children	Phase 3
Completed	`NCT01438645` - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy	N/A
Completed	`NCT01371656` - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Phase 3
Terminated	`NCT01048567` - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly	Phase 2
Terminated	`NCT01472211` - Water-based Zinc Intervention Trial in Zinc Deficient Children	Phase 0
Not yet recruiting	`NCT01382199` - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients	Phase 3
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT00760851` - Yogurt Study in Children 2-4 Years Old Attending Daycare	Phase 3