NCT01791608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

4 months

First QC Date

February 13, 2013

Last Update Submit

February 13, 2013

Conditions

DiarrheaAcute Respiratory Infection

Keywords

Child, PreschoolDietary ZincZinc sulfatezinc-glycine chelate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Adverse reaction

    Fortnightly. During 4 months of intervention

Study Arms (3)

Zinc sulphate

ACTIVE COMPARATOR

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

Dietary Supplement: Zinc sulfate as dietary supplementation

Zinc Amino Acid Chelate

EXPERIMENTAL

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

Dietary Supplement: Zinc amino acid chelate as dietary supplementation

Milk without fortification

PLACEBO COMPARATOR

Milk without zinc

Dietary Supplement: Milk without fortification without zinc

Interventions

Zinc sulfate as dietary supplementationDIETARY_SUPPLEMENT

Zinc sulfate as dietary supplementation

Zinc sulphate
Zinc amino acid chelate as dietary supplementationDIETARY_SUPPLEMENT

Zinc amino acid chelate as dietary supplementation

Zinc Amino Acid Chelate
Milk without fortification without zincDIETARY_SUPPLEMENT

Milk without fortification

Also known as: Milk without zinc
Milk without fortification

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who
  • Belong to institute FAN in Medellín
  • Attend full time to institute FAN (eight hours)
  • Have 2 to 5 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CES University

Medellín, Antioquia, Colombia

Location

Related Publications (1)

  • Sanchez J, Villada OA, Rojas ML, Montoya L, Diaz A, Vargas C, Chica J, Herrera AA. [Effect of zinc amino acid chelate and zinc sulfate in the incidence of respiratory infection and diarrhea among preschool children in child daycare centers]. Biomedica. 2014 Jan-Mar;34(1):79-91. doi: 10.1590/S0120-41572014000100011. Spanish.

    PMID: 24967861DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Zinc SulfateDietary SupplementsMilkZinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc CompoundsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBeveragesDairy ProductsMetals, HeavyElementsTransition ElementsMetals

Study Officials

  • Liliana LM Montoya, Master

    CES University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

CO(1)