NCT04061538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
529

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

August 2, 2019

Last Update Submit

August 15, 2019

Conditions

Diarrhoea;AcuteDiarrhea, Infantile

Keywords

zinc sulfateChildrenacute diarrheal diseases

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • diarrheic disease recurrence

    3 and 6 months

  • zinc serum concentration

    3, 9, 20, 31, 61, 91 and 121 days

Study Arms (2)

Zinc sulfate

EXPERIMENTAL

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

Dietary Supplement: zinc sulfate

Placebo

PLACEBO COMPARATOR

Placebo tablet, once a day for 10 days

Dietary Supplement: Placebo

Interventions

zinc sulfateDIETARY_SUPPLEMENT

zinc 20mg tablets

Zinc sulfate
PlaceboDIETARY_SUPPLEMENT

Sugar pill manufactured to mimic zinc 20mg tablet

Also known as: Placebo (for zinc)
Placebo

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Pediatrico de Coyoacan

Mexico City, 04000, Mexico

Location

Instituto Nacional de Pediatria

Mexico City, 04530, Mexico

Location

Hospital Pediatrico La Villa

Mexico City, 07050, Mexico

Location

Hospital Pediatrico de Iztapalapa

Mexico City, 09070, Mexico

Location

Hospital Pediátrico de Tacubaya

Mexico City, 11870, Mexico

Location

Centro de Salud Cultura Maya

Mexico City, 14230, Mexico

Location

Centro de Salud San Andres Totoltepec

Mexico City, 14400, Mexico

Location

Centro de Salud Topilejo

Mexico City, 14500, Mexico

Location

Hospital Materno Infantil de Xochimilco

Mexico City, 16090, Mexico

Location

MeSH Terms

Conditions

Diarrhea, Infantile

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Jorge Salmeron, PHD

    Universidad Nacional Autonoma de Mexico

    STUDY CHAIR

  • Edgar Sanchez, McS

    Universidad Nacional Autonoma de Mexico

    STUDY DIRECTOR

  • Marcelino Esparza Aguilar, PhD

    National Institute of Pediatrics in Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary researcher

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 20, 2019

Study Start

November 9, 2017

Primary Completion

September 14, 2018

Study Completion

January 31, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(9)