Zinc Supplementation and Severe and Recurrent Diarrhea

February 28, 2011 updated by: Hormozgan University of Medical Sciences

Evaluating the Impact of 3 Months Daily Zinc Supplementation on Incidence of Severe and Recurrent Diarrhea in 6 to 36 Months Age Children

Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas in 2009

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79145-3388
        • Hormozgan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
  • Inflammatory bowl disease and hypersensitivity to milk

Exclusion Criteria:

  • Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zinc sulfate
daily zinc supplementation for 3 months. (10mg daily for under 1 years old children and 20mg daily for above 1 years old children)
Drug: Zinc Supplement
10mg daily for under 1 years old children and 20mg daily for above 1 years old children
Other Names:
  • Zinc sulfate
  • Oral Zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diarrhea
Time Frame: 1 years
Incidence, Duration and frequency
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission for diarrhea
Time Frame: 1 year
Total number of admissions during the study period
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Investigators

  • Principal Investigator: Marzie Barchinejad, Hormozgan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zinc supplementation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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