Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
360 participants
INTERVENTIONAL
2012-03-31
2012-11-30
Brief Summary
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Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.
Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.
We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Zinc sulphate
Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate
Zinc sulfate as dietary supplementation
Zinc sulfate as dietary supplementation
Zinc Amino Acid Chelate
Preschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate
Zinc amino acid chelate as dietary supplementation
Zinc amino acid chelate as dietary supplementation
Milk without fortification
Milk without zinc
Milk without fortification without zinc
Milk without fortification
Interventions
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Zinc sulfate as dietary supplementation
Zinc sulfate as dietary supplementation
Zinc amino acid chelate as dietary supplementation
Zinc amino acid chelate as dietary supplementation
Milk without fortification without zinc
Milk without fortification
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Belong to institute FAN in Medellín
* Attend full time to institute FAN (eight hours)
* Have 2 to 5 years
Exclusion Criteria
* Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
* Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
* Failure to attend the educational institution for more than 10 days
* No consumption of zinc supplementation for more than 10 days, because of insistence to the school
2 Years
5 Years
ALL
Yes
Sponsors
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Nutreva S.A.S.
UNKNOWN
Foundation Child Care - FAN
OTHER
CES University
OTHER
Responsible Party
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Juliana Sanchez,MG
Principal investigator
Principal Investigators
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Liliana LM Montoya, Master
Role: STUDY_DIRECTOR
CES University
Locations
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CES University
Medellín, Antioquia, Colombia
Countries
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References
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Sanchez J, Villada OA, Rojas ML, Montoya L, Diaz A, Vargas C, Chica J, Herrera AA. [Effect of zinc amino acid chelate and zinc sulfate in the incidence of respiratory infection and diarrhea among preschool children in child daycare centers]. Biomedica. 2014 Jan-Mar;34(1):79-91. doi: 10.1590/S0120-41572014000100011. Spanish.
Other Identifiers
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ZAZO-01
Identifier Type: -
Identifier Source: org_study_id
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