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

Secretariat of Health

Status: Completed

Conditions: Diarrhoea;Acute; Diarrhea, Infantile

Treatments: Dietary Supplement: zinc sulfate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04061538

1474 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 529 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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529 participants in 2 patient groups, including a placebo group

Zinc sulfate

Experimental group

Description:

Zinc sulfate 20 mg by mouth, once a day for 10 days

Treatment:

Dietary Supplement: zinc sulfate

Placebo

Placebo Comparator group

Description:

Placebo tablet, once a day for 10 days

Treatment:

Dietary Supplement: Placebo