Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-randomized Field Trial in Rural Western Kenya
Brief 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.


Options:
A: Inclusion Criteria:

* Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (\<10th percentile of the National Center for Health Statistics \[NCHS\] median birth weight)
* Either sex
* Resides within 7 km of the hospital

Exclusion Criteria:

* Likely to leave the area of residence within 6 months of enrollment
* Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
* Non consent for participation
* Illness requiring hospitalization
* Twins
* Preterm
B: Inclusion Criteria:

4-6 months of age (stratified by HIV status) Infant able to take oral preparations Consent of parent/guardian HIV status obtained from mother and child

Exclusion Criteria:

Documented micronutrient supplementation other than vitamin A in the preceding month Less than 60% of mean weight for age by NCHS guidelines (micronutrient intervention obligatory according to WHO guidelines for management of severely malnourished children) Persistent diarrhea (\>=7 days) at the time of study enrollment Exclusive breastfeeding Infants in whom a second confirmatory HIV test cannot be obtained (when required) Co-enrollment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials
C: Inclusion Criteria:

* All children 2 to 59 months of age in households within 33 selected villages

Exclusion Criteria:

* Children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. Children of parents who do not give written informed consent for their participation will not be enrolled.
D: Inclusion Criteria:

Children who

* Belong to institute FAN in Medellín
* Attend full time to institute FAN (eight hours)
* Have 2 to 5 years

Exclusion Criteria:

Children who

* Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
* Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
* Failure to attend the educational institution for more than 10 days
* No consumption of zinc supplementation for more than 10 days, because of insistence to the school

Answer: C