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Completed

NCT Number: NCT01791608

Zinc Sulphate vs. Zinc Amino Acid Chelate

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.

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Key information

Conditions

Diarrhea Acute Respiratory Infection Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CES University

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc sulfate as dietary supplementation

Dietary Supplement

Zinc sulfate as dietary supplementation

Zinc amino acid chelate as dietary supplementation

Dietary Supplement

Zinc amino acid chelate as dietary supplementation

Milk without fortification without zinc

Dietary Supplement

Milk without fortification

Other names: Milk without zinc

Primary outcomes

  1. Incidence acute diarrheal disease and acute respiratory infection

    Time frame: 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 outcomes

  1. Adverse reaction

    Time frame: Fortnightly. During 4 months of intervention

    The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.

Sponsors and collaborators

Lead sponsor

CES University

Other

Collaborators

  • Foundation Child Care - FAN
  • Nutreva S.A.S.

Registry information

Official study title

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

Acronym: ZAZO

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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