NCT01571856

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

April 3, 2012

Last Update Submit

May 5, 2013

Conditions

Acute DiarrheaAcute Gastroenteritis

Keywords

Acute DiarrheaZincChildren

Outcome Measures

Primary Outcomes (1)

  • duration of diarrheal episode

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

    five days

Secondary Outcomes (2)

  • duration of hospitalization

    5 days

  • weight of stool

    5 days

Study Arms (2)

zinc sulfate

ACTIVE COMPARATOR

zinc sulphate solution.

Drug: Zinc Sulfate

cornstarch solution

PLACEBO COMPARATOR

cornstarch powder diluted in distilled water

Other: placebo

Interventions

Zinc SulfateDRUG

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

Also known as: Suplizinc
zinc sulfate
placeboOTHER

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

cornstarch solution

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all acute diarrhea

You may not qualify if:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • coinfections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Pediatrico Albina Patino

Cochabamba, Departamento de Cochabamba, Bolivia

Location

MeSH Terms

Interventions

Zinc Sulfate

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • Giuseppe Grandy, MD MSc

    Centro Pediatrico Albina de Patino

    STUDY DIRECTOR

  • Zaida Cama, MD

    Centro Pediatrico Albina Ptino

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Chief of Nutrition Center

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

May 1, 2013

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations

BO(1)