NCT01412723

Brief Summary

Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide. Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate. It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

August 5, 2011

Last Update Submit

April 10, 2012

Conditions

Iron Deficiency

Keywords

Iron DeficiencyChild, PreschoolDietary IronFerrous sulfateBis-glycino iron II

Outcome Measures

Primary Outcomes (1)

  • Ferritin

    The Ferritin level in blood will be measured at the beginning of the study as one of the most important inclusion criteria. This also will be the base line of the study. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) ferritin level will be measured again as the primary outcome measure.

    Up to 8 weeks

Secondary Outcomes (3)

  • Hemoglobin

    Up to 8 weeks

  • Infection

    Daily. During 2 months of intervention

  • Adverse reaction

    Daily. During 2 months of intervention

Study Arms (2)

Ferrous sulphate

ACTIVE COMPARATOR

Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk

Other: Ferrous sulfate as dietary supplementation

Iron Amino acid chelate

EXPERIMENTAL

Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk

Other: Iron amino acid chelated as dietary supplementation

Interventions

Ferrous sulfate as dietary supplementationOTHER

Ferrous sulfate as dietary supplementation

Ferrous sulphate
Iron amino acid chelated as dietary supplementationOTHER

Iron amino acid chelated as dietary supplementation

Iron Amino acid chelate

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
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 inclusive
  • Submit depleted levels of iron (ferritin level equal to or less than 24 mg/L)

You may not qualify if:

  • Children who
  • Submit anemia (hemoglobin level equal to or less than 11 g/dL)
  • Have not stool analysis before intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CES

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfateDietary Supplements

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ana M Herrera, PhD en Patología

    CES University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 9, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

April 11, 2012

Record last verified: 2012-04

Locations

CO(1)