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Zinc Supplementation and Severe and Recurrent Diarrhea

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ClinicalTrials.gov Identifier: NCT01306097
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : March 1, 2011
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment
Diarrhea Drug: Zinc Supplement

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2009
Primary Completion Date : January 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Diarrhea [ Time Frame: 1 years ]
    Incidence, Duration and frequency


Secondary Outcome Measures :
  1. Admission for diarrhea [ Time Frame: 1 year ]
    Total number of admissions during the study period



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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Marzie Barchinejad, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01306097     History of Changes
Other Study ID Numbers: Zinc supplementation
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: January 2009

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
Astringents
Dermatologic Agents