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

Primary Purpose

Diarrhoea;Acute, Diarrhea, Infantile

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
zinc sulfate
Placebo
Sponsored by
Instituto Nacional de Salud Publica, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhoea;Acute focused on measuring zinc sulfate, Children, acute diarrheal diseases

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital Pediatrico de Coyoacan
  • Instituto Nacional de Pediatria
  • Hospital Pediatrico La Villa
  • Hospital Pediatrico de Iztapalapa
  • Hospital Pediátrico de Tacubaya
  • Centro de Salud Cultura Maya
  • Centro de Salud San Andres Totoltepec
  • Centro de Salud Topilejo
  • Hospital Materno Infantil de Xochimilco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc sulfate

Placebo

Arm Description

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

Placebo tablet, once a day for 10 days

Outcomes

Primary Outcome Measures

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
Stool frequency
Number of stools during during the acute diarrheic disease

Secondary Outcome Measures

diarrheic disease recurrence
Number of acute diarrheal episode, after the first episode
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

Full Information

First Posted
August 2, 2019
Last Updated
August 15, 2019
Sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
UNICEF
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1. Study Identification

Unique Protocol Identification Number
NCT04061538
Brief Title
Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
Acronym
ESZnDiarrhea
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
UNICEF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea;Acute, Diarrhea, Infantile
Keywords
zinc sulfate, Children, acute diarrheal diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
529 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc sulfate
Arm Type
Experimental
Arm Description
Zinc sulfate 20 mg by mouth, once a day for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet, once a day for 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
zinc sulfate
Intervention Description
zinc 20mg tablets
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (for zinc)
Intervention Description
Sugar pill manufactured to mimic zinc 20mg tablet
Primary Outcome Measure Information:
Title
Diarrhea duration
Description
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
Time Frame
10 days
Title
Stool frequency
Description
Number of stools during during the acute diarrheic disease
Time Frame
10 days
Secondary Outcome Measure Information:
Title
diarrheic disease recurrence
Description
Number of acute diarrheal episode, after the first episode
Time Frame
3 and 6 months
Title
zinc serum concentration
Description
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
Time Frame
3, 9, 20, 31, 61, 91 and 121 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Salmeron, PHD
Organizational Affiliation
Universidad Nacional Autonoma de Mexico
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edgar Sanchez, McS
Organizational Affiliation
Universidad Nacional Autonoma de Mexico
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcelino Esparza Aguilar, PhD
Organizational Affiliation
National Institute of Pediatrics in Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pediatrico de Coyoacan
City
Mexico City
ZIP/Postal Code
04000
Country
Mexico
Facility Name
Instituto Nacional de Pediatria
City
Mexico City
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Pediatrico La Villa
City
Mexico City
ZIP/Postal Code
07050
Country
Mexico
Facility Name
Hospital Pediatrico de Iztapalapa
City
Mexico City
ZIP/Postal Code
09070
Country
Mexico
Facility Name
Hospital Pediátrico de Tacubaya
City
Mexico City
ZIP/Postal Code
11870
Country
Mexico
Facility Name
Centro de Salud Cultura Maya
City
Mexico City
ZIP/Postal Code
14230
Country
Mexico
Facility Name
Centro de Salud San Andres Totoltepec
City
Mexico City
ZIP/Postal Code
14400
Country
Mexico
Facility Name
Centro de Salud Topilejo
City
Mexico City
ZIP/Postal Code
14500
Country
Mexico
Facility Name
Hospital Materno Infantil de Xochimilco
City
Mexico City
ZIP/Postal Code
16090
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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

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