Zinc Sulphate vs. Zinc Amino Acid Chelate

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01791608

Acronym

ZAZO

Enrollment

360

Registered

2013-02-15

Start date

2012-03-31

Completion date

2012-11-30

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection, Diarrhea

Keywords

Child, Preschool, Dietary Zinc, Zinc sulfate, zinc-glycine chelate

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.

Interventions

DIETARY_SUPPLEMENTZinc sulfate as dietary supplementation

Zinc sulfate as dietary supplementation

DIETARY_SUPPLEMENTZinc amino acid chelate as dietary supplementation

Zinc amino acid chelate as dietary supplementation

DIETARY_SUPPLEMENTMilk without fortification without zinc

Milk without fortification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026