Clinical Trials Directory

Trials / Completed

CompletedNCT04061538

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
529 (actual)
Sponsor
Instituto Nacional de Salud Publica, Mexico · Academic / Other
Sex
All
Age
6 Months – 59 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTzinc sulfatezinc 20mg tablets
DIETARY_SUPPLEMENTPlaceboSugar pill manufactured to mimic zinc 20mg tablet

Timeline

Start date
2017-11-09
Primary completion
2018-09-14
Completion
2019-01-31
First posted
2019-08-20
Last updated
2019-08-20

Locations

9 sites across 1 country: Mexico

Source: ClinicalTrials.gov record NCT04061538. Inclusion in this directory is not an endorsement.