Zinc Sulphate vs. Zinc Amino Acid Chelate

Phase 4

Completed

• Conditions: Diarrhea; Acute Respiratory Infection
• Interventions: Dietary Supplement: Zinc sulfate as dietary supplementation; Dietary Supplement: Zinc amino acid chelate as dietary supplementation; Dietary Supplement: Milk without fortification without zinc

• Registration Number: NCT01791608
• Lead Sponsor: CES University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-07
• Study Completion: 2012-11
• Status Verified: 2013-02
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Last Update Submitted: 2013-02-13
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc sulphate	Zinc sulfate as dietary supplementation	Preschool children healthy enrolled in FAN Foundation of Medellin, which will be supplied with zinc sulphate
Zinc Amino Acid Chelate	Zinc amino acid chelate as dietary supplementation	Preschool children healthy enrolled in FAN Foundation of Medellin , which will be supplied with zinc amino acid chelate
Milk without fortification	Milk without fortification without zinc	Milk without zinc

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CES University; 🇨🇴 Medellín, Antioquia, Colombia