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

Diarrhea, Infantile Clinical Trial

— ESZnDiarrhea  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061538
• Other study ID #: 1474
• Status: Completed
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2019
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: January 31, 2019
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea, Infantile
• Diarrhoea;Acute

Intervention

Dietary Supplement:
• zinc sulfate
zinc 20mg tablets
• Placebo
Sugar pill manufactured to mimic zinc 20mg tablet

Locations

Country	Name	City	State
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	Hospital Materno Infantil de Xochimilco	Mexico City
Mexico	Hospital Pediatrico de Coyoacan	Mexico City
Mexico	Hospital Pediatrico de Iztapalapa	Mexico City
Mexico	Hospital Pediátrico de Tacubaya	Mexico City
Mexico	Hospital Pediatrico La Villa	Mexico City
Mexico	Instituto Nacional de Pediatria	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico	UNICEF

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stool frequency	Number of stools during during the acute diarrheic disease	10 days
Secondary	diarrheic disease recurrence	Number of acute diarrheal episode, after the first episode	3 and 6 months
Secondary	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