Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Trial of Zinc Supplementation in Cholera Patients
Brief Summary: Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be \>4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.


Options:
A: Inclusion Criteria:

* Children aged between 3-14 years hospitalized at ICDDR, B presenting with cholera within 24 hours of onset.
* Stool output more than 4ml/kg/hour within the first 6 hours of observation period.
* Positive dark field examination

Exclusion Criteria:

* Unable to rehydrate within 6 hours
* Negative dark field examination
* Systemic illness requiring immediate administration of antibiotics.
* Received antibiotics in the 24 hours prior to hospitalization
* Patients presenting with bloody mucoid diarrhea
* Unconscious or medical emergencies
B: Inclusion Criteria:

* Children 6-24 months of age with acute childhood diarrheal illness.

Exclusion Criteria:

* Severe dehydration, suspected cholera or pneumonia, chronic illness, bipedal edema (seriously ill children will be referred to ICDDR,B/Shishu Hospital).
* The child is currently receiving zinc (as a treatment or supplement)
* Wt/length, z-score below -3 (these children will be referred to ICDDR,B/ Shishu Hospital)
* Already participating in another study involving nutritional or therapeutic interventions
C: Inclusion Criteria:

* Males
* Age 1 month up to 36 months:
* Passage of 3 or more liquid stools in a 24-hour period, every day, and at least one in 12 hours prior to admission
* Diarrhea for \< 7days (168 hours)

Exclusion Criteria:

* severe systemic illness requiring intensive care management; systemic infection will be suspected if there is a general appearance of non-wellbeing with one or more of the following symptoms: shrill cry and irritability, temperature instability, hypotension, hypoglycemia, altered sensorium, lethargy or refusal of feeds, abdominal distension.
* chronic illness like Tuberculosis, Nephrotic syndrome, malignancy etc or any surgical disorder.
* severe malnutrition (weight for age \<65% of NCHS median
* gross blood in stool
* refusal of consent
D: 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

Answer: A