Clinical trial NCT04061538: Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
Official title: Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea;Acute
Diarrhea, Infantile
Keywords: zinc sulfate
Children
acute diarrheal diseases
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2019-08-20
Enrollment: 529
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diarrhea duration
timeFrame: 10 days
measure: Stool frequency
timeFrame: 10 days
Secondary outcomes:
measure: diarrheic disease recurrence
timeFrame: 3 and 6 months
measure: zinc serum concentration
timeFrame: 3, 9, 20, 31, 61, 91 and 121 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Pediatrico de Coyoacan
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatria
city: Mexico City
country: Mexico
facility: Hospital Pediatrico La Villa
city: Mexico City
country: Mexico
facility: Hospital Pediatrico de Iztapalapa
city: Mexico City
country: Mexico
facility: Hospital Pediátrico de Tacubaya
city: Mexico City
country: Mexico
facility: Centro de Salud Cultura Maya
city: Mexico City
country: Mexico
facility: Centro de Salud San Andres Totoltepec
city: Mexico City
country: Mexico
facility: Centro de Salud Topilejo
city: Mexico City
country: Mexico
facility: Hospital Materno Infantil de Xochimilco
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Jorge Salmeron, PHD
role: STUDY_CHAIR
affiliation: Universidad Nacional Autonoma de Mexico
name: Edgar Sanchez, McS
role: STUDY_DIRECTOR
affiliation: National Institute of Pediatrics in Mexico
name: Marcelino Esparza Aguilar, PhD
role: PRINCIPAL_INVESTIGATOR
References: