Zinc Sulphate vs. Zinc Amino Acid Chelate

NCT ID: NCT01791608

Last Updated: 2013-02-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diarrhea Acute Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zinc sulphate

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

Group Type ACTIVE_COMPARATOR

Zinc sulfate as dietary supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Zinc amino acid chelate as dietary supplementation

Intervention Type DIETARY_SUPPLEMENT

Zinc amino acid chelate as dietary supplementation

Milk without fortification

Milk without zinc

Group Type PLACEBO_COMPARATOR

Milk without fortification without zinc

Intervention Type DIETARY_SUPPLEMENT

Milk without fortification

Interventions

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Zinc sulfate as dietary supplementation

Zinc sulfate as dietary supplementation

Intervention Type DIETARY_SUPPLEMENT

Zinc amino acid chelate as dietary supplementation

Zinc amino acid chelate as dietary supplementation

Intervention Type DIETARY_SUPPLEMENT

Milk without fortification without zinc

Milk without fortification

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Milk without zinc

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutreva S.A.S.

UNKNOWN

Sponsor Role collaborator

Foundation Child Care - FAN

OTHER

Sponsor Role collaborator

CES University

OTHER

Sponsor Role lead

Responsible Party

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Juliana Sanchez,MG

Principal investigator

Responsibility Role 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

Site Status

Countries

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Colombia

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.

Reference Type DERIVED
PMID: 24967861 (View on PubMed)

Other Identifiers

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ZAZO-01

Identifier Type: -

Identifier Source: org_study_id

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