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Completed

NCT Number: NCT01571856

Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants

The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.

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Key information

Conditions

Acute Diarrhea Acute Gastroenteritis

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Pediatrico Albina Patino

Cochabamba, Bolivia

About this study

Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.

Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.

Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all acute diarrhea

Exclusion criteria

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • coinfections

Treatment and study plan

zinc sulfate

Drug

zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.

Other names: Suplizinc

Placebo

Other

cornstarch powder diluted in distilled water, dosage 2.5 ml per day

Primary outcomes

  1. duration of diarrheal episode

    Time frame: five days

    duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.

Secondary outcomes

  1. duration of hospitalization

    Time frame: 5 days

    participants will be followed for the duration of hospital stay, an expected average of 5 days

  2. weight of stool

    Time frame: 5 days

    we expected the weight of the stool will diminish by about 5 days

Sponsors and collaborators

Lead sponsor

Centro Pediatrico Albina de Patino

Other

Registry information

Official study title

Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 5, 2012
Registry last updated
May 7, 2013

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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