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Zinc Sulphate vs. Zinc Amino Acid Chelate (ZAZO)

Primary Purpose

Diarrhea, Acute Respiratory Infection

Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Zinc sulfate as dietary supplementation
Zinc amino acid chelate as dietary supplementation
Milk without fortification without zinc
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring Child, Preschool, Dietary Zinc, Zinc sulfate, zinc-glycine chelate

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Children who

  • Belong to institute FAN in Medellín
  • Attend full time to institute FAN (eight hours)
  • Have 2 to 5 years

Exclusion Criteria:

Children who

  • 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

Sites / Locations

  • CES University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Zinc sulphate

Zinc Amino Acid Chelate

Milk without fortification

Arm Description

Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate

Preschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate

Milk without zinc

Outcomes

Primary Outcome Measures

Incidence acute diarrheal disease and acute respiratory infection
Preschool children will drink fortified milk with zinc amino acid chelate, zinc sulfate or milk without fortification. Fortnightly monitoring will be investigating the presence of infection (acute diarrheal disease and respiratory infections). Supervision and monitoring will be carried out for four months.

Secondary Outcome Measures

Adverse reaction
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.

Full Information

First Posted
February 13, 2013
Last Updated
February 13, 2013
Sponsor
CES University
Collaborators
Nutreva S.A.S., Foundation Child Care - FAN
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1. Study Identification

Unique Protocol Identification Number
NCT01791608
Brief Title
Zinc Sulphate vs. Zinc Amino Acid Chelate
Acronym
ZAZO
Official Title
Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University
Collaborators
Nutreva S.A.S., Foundation Child Care - FAN

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Acute Respiratory Infection
Keywords
Child, Preschool, Dietary Zinc, Zinc sulfate, zinc-glycine chelate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc sulphate
Arm Type
Active Comparator
Arm Description
Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate
Arm Title
Zinc Amino Acid Chelate
Arm Type
Experimental
Arm Description
Preschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate
Arm Title
Milk without fortification
Arm Type
Placebo Comparator
Arm Description
Milk without zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc sulfate as dietary supplementation
Intervention Description
Zinc sulfate as dietary supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc amino acid chelate as dietary supplementation
Intervention Description
Zinc amino acid chelate as dietary supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk without fortification without zinc
Other Intervention Name(s)
Milk without zinc
Intervention Description
Milk without fortification
Primary Outcome Measure Information:
Title
Incidence acute diarrheal disease and acute respiratory infection
Description
Preschool children will drink fortified milk with zinc amino acid chelate, zinc sulfate or milk without fortification. Fortnightly monitoring will be investigating the presence of infection (acute diarrheal disease and respiratory infections). Supervision and monitoring will be carried out for four months.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Adverse reaction
Description
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.
Time Frame
Fortnightly. During 4 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children who Belong to institute FAN in Medellín Attend full time to institute FAN (eight hours) Have 2 to 5 years Exclusion Criteria: Children who 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liliana LM Montoya, Master
Organizational Affiliation
CES University
Official's Role
Study Director
Facility Information:
Facility Name
CES University
City
Medellín
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

Citations:
PubMed Identifier
24967861
Citation
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.
Results Reference
derived

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Zinc Sulphate vs. Zinc Amino Acid Chelate

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