Diarrhea, Infantile, Diarrhoea;Acute
Conditions
Keywords
zinc sulfate, Children, acute diarrheal diseases
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTzinc sulfate
zinc 20mg tablets
DIETARY_SUPPLEMENTPlacebo
Sugar pill manufactured to mimic zinc 20mg tablet
Sponsors
UNICEF
Instituto Nacional de Salud Publica, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea duration | 10 days | 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 |
| Stool frequency | 10 days | Number of stools during during the acute diarrheic disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diarrheic disease recurrence | 3 and 6 months | Number of acute diarrheal episode, after the first episode |
| zinc serum concentration | 3, 9, 20, 31, 61, 91 and 121 days | 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 |
Countries
Mexico
Outcome results
None listed