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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention Kenya Medical Research Institute International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00530829 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea |
Drug: zinc |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-Randomized Field Trial in Rural Western Kenya |
| Estimated Enrollment: | 1300 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Mothers recieve a blister pack of zinc tablets in home every two months for use when child in home under 5 years has diarrhea. ORS satchets also given. Instructions on when and how to use zinc and ORS and when to take child in clinic are given by community health worker. Zinc will also be given in clinic if child visits clinic with diarrhea and has not yet started zinc at home.
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Drug: zinc
10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
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2: Active Comparator
Mothers recieve ORS satchets at home every two months for use when child in home under 5 years has diarrhea. Instructions on when and how to use ORS and when to take child in clinic are given by community health worker. Zinc will be given in clinic if child visits clinic with diarrhea.
|
Drug: zinc
10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
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Eligibility| Ages Eligible for Study: | 2 Months to 4 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Daniel R Feikin, MD | 254 722200075 | dfeikin@ke.cdc.gov |
| Contact: Robert F Breiman, MD | 254 722205248 | rbreiman@ke.cdc.gov |
| Kenya | |
| Kenya Medical Research Institute | Recruiting |
| Kisumu, Kenya | |
| Contact: Daniel Feikin, MD 254 7222 00075 dfeikin@ke.cdc.gov | |
| Sub-Investigator: John Vulule, PhD | |
| Principal Investigator: | Daniel R Feikin, MD | Centers for Disease Control and Prevention |
More Information
| Responsible Party: | CDC ( Daniel Feikin, Medical epidemiologist ) |
| Study ID Numbers: | CDC-NCPDCID-4678 |
| Study First Received: | September 17, 2007 |
| Last Updated: | July 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00530829 |
| Health Authority: | United States: Federal Government |
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diarrhea zinc oral rehydration therapy |
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Signs and Symptoms Diarrhea Signs and Symptoms, Digestive Zinc |
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Growth Substances Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |
