ZAZO: Zinc Sulphate vs. Zinc Amino Acid Chelate

Sponsor

CES University (Other)

Overall Status

Completed

CT.gov ID

NCT01791608

Collaborator

Nutreva S.A.S. (Other), Foundation Child Care - FAN (Other)

360

Enrollment

Location

Arms

Duration (Months)

44.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea Acute Respiratory Infection	Dietary Supplement: Zinc sulfate as dietary supplementation Dietary Supplement: Zinc amino acid chelate as dietary supplementation Dietary Supplement: Milk without fortification without zinc	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence acute diarrheal disease and acute respiratory infection [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.

Secondary Outcome Measures

Adverse reaction [Fortnightly. During 4 months of intervention]
The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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