Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.
Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zinc sulfate | Active Comparator | zinc sulphate solution. |
|
| cornstarch solution | Placebo Comparator | cornstarch powder diluted in distilled water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Sulfate | Drug | zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of diarrheal episode | duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days. | five days |
| Measure | Description | Time Frame |
|---|---|---|
| duration of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 5 days | 5 days |
| weight of stool | we expected the weight of the stool will diminish by about 5 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Grandy, MD MSc | Centro Pediatrico Albina de Patino | Study Director |
| Zaida Cama, MD | Centro Pediatrico Albina Ptino | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Pediatrico Albina Patino | Cochabamba | Cochabamba | Bolivia |
Not provided
| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Other | cornstarch powder diluted in distilled water, dosage 2.5 ml per day |
|
| 5 days |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |