Zinc Sulphate vs. Zinc Amino Acid Chelate

Diarrhea Clinical Trial

— ZAZO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791608
• Other study ID #: ZAZO-01
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2013
• Last updated: February 13, 2013
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: CES University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Diarrhea
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Colombia	CES University	Medellín	Antioquia

Sponsors (3)

Lead Sponsor	Collaborator
CES University	Fundación de Atención a la Niñez FAN, Nutreva S.A.S.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence acute diarrheal disease and acute respiratory infection	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.	Up to 16 weeks	No
Secondary	Adverse reaction	The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea and vomiting.	Fortnightly. During 4 months of intervention	Yes