Inclusion criteria Children of age 3-59 months with an acute diarrhea episode who will be prescribed oral rehydration salts (ORS) per WHO guidelines. (Note: documentation of ORS administration is not required.) Signed informed consent by the caregivers. Exclusion criteria Severe dehydration Abnormally sleepy or lethargic. Sunken eyes. Drinking poorly or not at all. Tachycardia. Tachypnea. Markedly reduced skin turgor. Known hypersensitivity to zinc sulfate. Having any medical condition that may interfere with the subject’s ability to sense or discriminate between tastes. Description of study days Pre-trial evaluation At the baseline visit, informed consent will be demographic obtained, patients’ eligibility confirmed, data recorded, and clinical symptoms of the diarrhea episode evaluated. Instructions will be given regarding the dosage, acceptability criteria, evaluation and study procedure requirements. Study days Patients will be followed at home with daily recordings of the 2 endpoints. Drug will be administered and evaluation will be done by the caregivers. Phone calls to or from caregivers should not be done, as this will introduce needless bias. Endpoint evaluation must be done in person with the caregiver at the follow-up visit, not by telephone or other electronic method. Follow-up visit This will occur following at least 10 days of treatment. Clinical Clinical signs and symptoms will be evaluated. Diarrhea episode will be described regarding the duration and severity. Adverse events will be documented and drug accountability recorded. Safety monitoring Safety will be monitored by the caregivers.
Inclusion criteria Children of age 3-59 months with an acute diarrhea episode who will be prescribed oral rehydration salts (ORS) per WHO guidelines. (Note: documentation of ORS administration is not required.) Signed informed consent by the caregivers. Exclusion criteria Severe dehydration Abnormally sleepy or lethargic. Sunken eyes. Drinking poorly or not at all. Tachycardia. Tachypnea. Markedly reduced skin turgor. Known hypersensitivity to zinc sulfate. Having any medical condition that may interfere with the subject’s ability to sense or discriminate between tastes. Description of study days Pre-trial evaluation At the baseline visit, informed consent will be obtained, patients’ eligibility confirmed, demographic data recorded, and clinical symptoms of the diarrhea episode evaluated. Instructions will be given regarding the dosage, acceptability criteria, evaluation and study procedure requirements. Study days Patients will be followed at home with daily recordings of the 2 endpoints. Drug will be administered and evaluation will be done by the caregivers. Phone calls to or from caregivers should not be done, as this will introduce needless bias. Endpoint evaluation must be done in person with the caregiver at the follow-up visit, not by telephone or other electronic method. Follow-up visit This will occur following at least 10 days of treatment. Clinical Clinical signs and symptoms will be evaluated. Diarrhea episode will be described regarding the duration and severity. Adverse events will be documented and drug accountability recorded. Safety monitoring Safety will be monitored by the caregivers.