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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571856

Enrollment

Registered

2012-04-05

Start date

2011-07-31

Completion date

2013-05-31

Last updated

2013-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diarrhea, Acute Gastroenteritis

Keywords

Acute Diarrhea, Zinc, Children

Brief summary

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.

Detailed description

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.

Interventions

DRUGZinc Sulfate

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

OTHERplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 6 Months

Healthy volunteers

Inclusion criteria

* all acute diarrhea

Exclusion criteria

* Severe malnourishment * Severe dehydration * Systemic infections * coinfections

Design outcomes

Primary

Measure	Time frame	Description
duration of diarrheal episode	five days	duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.

Secondary

Measure	Time frame	Description
duration of hospitalization	5 days	participants will be followed for the duration of hospital stay, an expected average of 5 days
weight of stool	5 days	we expected the weight of the stool will diminish by about 5 days

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026