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Zinc Supplementation and Severe and Recurrent Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01306097
First received: February 28, 2011
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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


Condition Intervention
Diarrhea
 Drug: Zinc Supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating the Impact of 3 Months Daily Zinc Supplementation on Incidence of Severe and Recurrent Diarrhea in 6 to 36 Months Age Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • Diarrhea [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    Incidence, Duration and frequency


Secondary Outcome Measures:
  • Admission for diarrhea [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Total number of admissions during the study period


Enrollment: 100
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306097

Locations
Iran, Islamic Republic of
Hormozgan University of medical sciences
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
Principal Investigator: Marzie Barchinejad Hormozgan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Marzie Barchinejad, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01306097     History of Changes
Other Study ID Numbers: Zinc supplementation
Study First Received: February 28, 2011
Last Updated: February 28, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Zinc Supplement
Diarrhea
Sever Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013