Zinc Sulphate vs. Zinc Amino Acid Chelate (ZAZO)

CES University

Status and phase: Completed; Phase 4

Conditions: Acute Respiratory Infection; Diarrhea

Treatments: Dietary Supplement: Zinc sulfate as dietary supplementation; Dietary Supplement: Zinc amino acid chelate as dietary supplementation; Dietary Supplement: Milk without fortification without zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT01791608

ZAZO-01

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups, including a placebo group

Zinc sulphate

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Zinc sulfate as dietary supplementation

Zinc Amino Acid Chelate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Zinc amino acid chelate as dietary supplementation

Milk without fortification

Placebo Comparator group

Description:

Milk without zinc

Treatment:

Dietary Supplement: Milk without fortification without zinc