Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
- Conditions
- Diarrhea, InfantileDiarrhoea;Acute
- Interventions
- Dietary Supplement: zinc sulfateDietary Supplement: Placebo
- Registration Number
- NCT04061538
- Lead Sponsor
- Instituto Nacional de Salud Publica, Mexico
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 529
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc sulfate zinc sulfate Zinc sulfate 20 mg by mouth, once a day for 10 days Placebo Placebo Placebo tablet, once a day for 10 days
- Primary Outcome Measures
Name Time Method Stool frequency 10 days Number of stools during during the acute diarrheic disease
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
- Secondary Outcome Measures
Name Time Method 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
diarrheic disease recurrence 3 and 6 months Number of acute diarrheal episode, after the first episode
Trial Locations
- Locations (9)
Hospital Materno Infantil de Xochimilco
🇲🇽Mexico City, Mexico
Hospital Pediatrico de Coyoacan
🇲🇽Mexico City, Mexico
Hospital Pediatrico La Villa
🇲🇽Mexico City, Mexico
Centro de Salud Cultura Maya
🇲🇽Mexico City, Mexico
Centro de Salud San Andres Totoltepec
🇲🇽Mexico City, Mexico
Centro de Salud Topilejo
🇲🇽Mexico City, Mexico
Instituto Nacional de Pediatria
🇲🇽Mexico City, Mexico
Hospital Pediátrico de Tacubaya
🇲🇽Mexico City, Mexico
Hospital Pediatrico de Iztapalapa
🇲🇽Mexico City, Mexico