Zinc Sulphate vs. Zinc Amino Acid Chelate

Study Overview
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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.

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

Conditions
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Diarrhea, Acute Respiratory Infection

Intervention / Treatment
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* Dietary Supplement: Zinc sulfate as dietary supplementation
* Dietary Supplement: Zinc amino acid chelate as dietary supplementation
* Dietary Supplement: Milk without fortification without zinc


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zinc sulphate<br>Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate | Dietary Supplement: Zinc sulfate as dietary supplementation<br>* Zinc sulfate as dietary supplementation<br>|
| Experimental: Zinc Amino Acid Chelate<br>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<br>* Zinc amino acid chelate as dietary supplementation<br>|
| Placebo Comparator: Milk without fortification<br>Milk without zinc | Dietary Supplement: Milk without fortification without zinc<br>* Milk without fortification<br>* Other names: Milk without zinc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 16 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Preschool, Dietary Zinc, Zinc sulfate, zinc-glycine chelate