A Phase 3 interventional study of zinc in Diarrhea, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Kenya. Open to participants aged 2 Months to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-09.
Sponsored by Centers for Disease Control and Prevention · Phase 3, Interventional, and Treatment
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.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 3,000 is above the median of 136 across 713 interventional studies indexed under Diarrhea.
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Exclusion Criteria:
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.
Drug: zinc
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
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only
Time frame: One year
To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic decreases the likelihood of recurrent diarrhea episodes, acute respiratory infections, and antimicrobial use
Time frame: one year
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Centers for Disease Control and Prevention