Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age

Study Overview
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Brief Summary
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This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.

Detailed Description
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In Mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. Consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen. Zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. The recommendation of including zinc in the treatment of ADD is not part of the Mexican normativity. The evaluation of the efficacy of zinc administration in Mexican children is insufficient and a program or national strategy for zinc treatment does not exist. The objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of Mexico City.

Official Title
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Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age

Conditions
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Diarrhoea;Acute, Diarrhea, Infantile

Intervention / Treatment
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* Dietary Supplement: zinc sulfate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes Children attended in the sentinel centers Clinical diagnosis of acute diarrhea disease Parents have not planned moving to other location in a time period of at least one year. Exclusion Criteria: Deficient intestinal absorption syndrome Acrodermatitis enterohepatic Zinc sulfate hypersensitivity Leucine metabolic disorders Secondary lactose intolerance Galactosemia lactase primary deficiency Allergy to cow milk protein Children that are supplemented with zinc for the last 6 months

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc sulfate<br>Zinc sulfate 20 mg by mouth, once a day for 10 days | Dietary Supplement: zinc sulfate<br>* zinc 20mg tablets<br>|
| Placebo Comparator: Placebo<br>Placebo tablet, once a day for 10 days | Dietary Supplement: Placebo<br>* Sugar pill manufactured to mimic zinc 20mg tablet<br>* Other names: Placebo (for zinc);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea duration | Number of hours from the inclusion of the patient until the end of the diarrhea. The end of diarrhea was defined as the last diarrhea evacuation followed by a 48 hr period without diarrhea | 10 days | 
| Stool frequency | Number of stools during during the acute diarrheic disease | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diarrheic disease recurrence | Number of acute diarrheal episode, after the first episode | 3 and 6 months | 
| zinc serum concentration | Difference of zinc serum concentration after the oral treatment for 10 days with 20 mg of zinc, and its correlation with the duration of diarrhea , the number of total stools and relapse rates | 3, 9, 20, 31, 61, 91 and 121 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc sulfate, Children, acute diarrheal diseases