NCT00682955

Brief Summary

This project is aimed to evaluate the efficacy of two different zinc formulations (dispersible Zinc tablets versus Zinc suspension) for the treatment of acute diarrhea in hospital based settings. Additionally we intend to compare the effectiveness of treatments of different groups on the basis of usage of Zinc in the treatment of diarrhoea, and to monitor additional treatment components such as ORS, antibiotic usage rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

May 20, 2008

Last Update Submit

May 21, 2008

Conditions

Incidence of Acute DiarrheaIncidence of Abdominal Pain

Keywords

DiarrheaZinc SulphateEfficacy

Outcome Measures

Primary Outcomes (1)

  • Comparison of Efficacy of the two different Zinc Sulphate formulations

    9 months

Secondary Outcomes (1)

  • Comparison of side effects of the two different Zinc Sulphate formulations used

    9 months

Study Arms (2)

B

ACTIVE COMPARATOR

This group has been given Zinc Sulphate in Suspension Form.

Drug: Zinc Sulphate

A

ACTIVE COMPARATOR

This group has been given Tablets of Zinc Sulphate.

Drug: Zinc Sulphate

Interventions

Zinc SulphateDRUG

20 mg per day, Zinc Sulphate tablet has been given to subjects.

Also known as: Zincol
A

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 6 months to 5 years of age
  • Presented with passage of 3 or more loose or watery stools
  • Caretakers are willing to let their child to participate in the study.

You may not qualify if:

  • Failure to produce consent.
  • Children with severe malnutrition or having chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Civil Hospital

Hyderābād, Sindh, 75300, Pakistan

Location

National Institute of Child Health

Karachi, Sindh, 75300, Pakistan

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 23, 2008

Study Start

August 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations

PA(2)