Zinc Sulphate vs. Zinc Amino Acid Chelate (ZAZO)

February 13, 2013 updated by: Juliana Sanchez,MG, CES University

Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • CES University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zinc sulphate
Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate
Dietary supplement: Zinc sulfate as dietary supplementation
Zinc sulfate as dietary supplementation
Experimental: Zinc Amino Acid Chelate
Preschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate
Dietary supplement: Zinc amino acid chelate as dietary supplementation
Zinc amino acid chelate as dietary supplementation
Placebo Comparator: Milk without fortification
Milk without zinc
Dietary supplement: Milk without fortification without zinc
Milk without fortification
Other Names:
  • Milk without zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence acute diarrheal disease and acute respiratory infection
Time Frame: Up to 16 weeks
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.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reaction
Time Frame: Fortnightly. During 4 months of intervention
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.
Fortnightly. During 4 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CES University

Collaborators

Nutreva S.A.S.
Foundation Child Care - FAN

Investigators

  • Study Director: Liliana LM Montoya, Master, CES University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAZO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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