Zinc Sulphate vs. Zinc Amino Acid Chelate (ZAZO)

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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