Health Condition 1: null- Children with acute diarrhea
Conditions
Interventions
Intervention1: zinc 10 mg dose: Administration: oral
Duration: 14 days, Dose per day: once daily
Intervention2: zinc 5 mg dose: Administration: oral
Duration: 14 days, Dose per day: once daily
Control Intervention1: zinc 20 mg dose (standard treatment): Administration: oral
Duration: 14 days, Dose per day: once daily
Sponsors
Center For Public Health Kinetics
Eligibility
Inclusion criteria
Inclusion criteria: a. Males and females 6 to 59 completed months of age b. Acute diarrhoea of less than 72 hours at the time of screening c. Dysentery, defined as visible blood in the stool, of less than 72 hours at the time of screening d. Likely to stay within the study area for the next 2 months e. Written informed consent from caretaker
Exclusion criteria
Exclusion criteria: a.Presence of severe acute malnutrition (WHZ b.Presence of severe dehydration that cannot be corrected in 4 to 6 hours c.Signs of severe pneumonia (WHO definition of pneumonia with danger signs), sepsis, RDT-confirmed malaria or other severe illness d. Previously or currently enrolled in the study e. child currently enrolled in another study f. Other child in the family is currently enrolled in the study in the same household g. Not intending to remain in study area for the duration of the study h. Parents refuse participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhoea duration -Diarrhoea continuing beyond five days -Total number of loose or watery stools after enrollment -Proportion of children vomiting within 30 minutes of administration of zinc tablet Timepoint: From enrollment until the recovery of the diarrheal episode (2 diarrheal free days) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Serious adverse events (life-threatening or requiring hospitalization) -Diarrhoea continuing beyond three days -Acceptability of the different doses of zinc -Mean serum plasma zinc levels. -Cause-specific illness prevalence at 30 and 60 days post-acute illness -Treatment adherence /duration Timepoint: -From enrollment till 60 days follow up -From randomization till resolution of diarrhoea -From randomization till 14 days of supplementation period - At Days 1,3, 7, 15, 21 and 30 - Day 30 and Day 60 -From randomization till 14 days of supplementation period | — |
Countries
India, United Republic of Tanzania
Contacts
Public ContactDr P K Gupta
Center For Public Health Kinetics
Outcome results
None listed