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

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea, Infantile; Diarrhoea;Acute
• Intervention / Treatment: Dietary supplement: zinc sulfate; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 529
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 04530
    • Instituto Nacional de Pediatría
  • Mexico City, Mexico, 04000
    • Hospital Pediatrico de Coyoacan
  • Mexico City, Mexico, 07050
    • Hospital Pediatrico La Villa
  • Mexico City, Mexico, 09070
    • Hospital Pediatrico de Iztapalapa
  • Mexico City, Mexico, 11870
    • Hospital Pediátrico de Tacubaya
  • Mexico City, Mexico, 14230
    • Centro de Salud Cultura Maya
  • Mexico City, Mexico, 14400
    • Centro de Salud San Andres Totoltepec
  • Mexico City, Mexico, 14500
    • Centro de Salud Topilejo
  • Mexico City, Mexico, 16090
    • Hospital Materno Infantil de Xochimilco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc sulfate; Zinc sulfate 20 mg by mouth, once a day for 10 days	Dietary supplement: zinc sulfate; zinc 20mg tablets
Placebo Comparator: Placebo; Placebo tablet, once a day for 10 days	Dietary supplement: Placebo; Sugar pill manufactured to mimic zinc 20mg tablet; Other Names: Placebo (for zinc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Stool frequency	Number of stools during during the acute diarrheic disease	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diarrheic disease recurrence	Number of acute diarrheal episode, after the first episode	3 and 6 months
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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Salud Publica, Mexico
• Collaborators: UNICEF
• Investigators: Study Chair: Jorge Salmeron, PHD, Universidad Nacional Autonoma de Mexico; Study Director: Edgar Sanchez, McS, Universidad Nacional Autonoma de Mexico; Principal Investigator: Marcelino Esparza Aguilar, PhD, National Institute of Pediatrics in Mexico

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Children; zinc sulfate; acute diarrheal diseases
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Diarrhea, Infantile; Physiological Effects of Drugs; Dermatologic Agents; Trace Elements; Micronutrients; Astringents; Zinc; Zinc Sulfate
• Other Study ID Numbers: 1474 (CSL Behring)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No