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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

NCT04061538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2019-08-20

No results posted yet for this study

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.

Conditions

  • Diarrhoea;Acute
  • Diarrhea, Infantile

Interventions

DIETARY_SUPPLEMENT

zinc sulfate

zinc 20mg tablets

DIETARY_SUPPLEMENT

Placebo

Sugar pill manufactured to mimic zinc 20mg tablet

Sponsors & Collaborators

  • UNICEF

    collaborator OTHER

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Jorge Salmeron, PHD · Universidad Nacional Autonoma de Mexico

  • Edgar Sanchez, McS · Universidad Nacional Autonoma de Mexico

  • Marcelino Esparza Aguilar, PhD · National Institute of Pediatrics in Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2018-09-14
Completion
2019-01-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061538 on ClinicalTrials.gov