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Completed

NCT Number: NCT04061538

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

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Cultura Maya, Mexico City, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc sulfate

Dietary Supplement

zinc 20mg tablets

Placebo

Dietary Supplement

Sugar pill manufactured to mimic zinc 20mg tablet

Other names: Placebo (for zinc)

Primary outcomes

  1. Diarrhea duration

    Time frame: 10 days

    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

  2. Stool frequency

    Time frame: 10 days

    Number of stools during during the acute diarrheic disease

Secondary outcomes

  1. diarrheic disease recurrence

    Time frame: 3 and 6 months

    Number of acute diarrheal episode, after the first episode

  2. zinc serum concentration

    Time frame: 3, 9, 20, 31, 61, 91 and 121 days

    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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Salud Publica, Mexico

Other

Collaborators

  • UNICEF

Registry information

Acronym: ESZnDiarrhea

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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