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Ferrous Sulfate Versus Iron Amino Acid Chelate

NCT01412723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2012-04-11

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Ferrous sulfate as dietary supplementation

Ferrous sulfate as dietary supplementation

OTHER

Iron amino acid chelated as dietary supplementation

Iron amino acid chelated as dietary supplementation

Sponsors & Collaborators

  • Nutreva S.A.S.

    collaborator UNKNOWN

  • Foundation Child Care - FAN

    collaborator OTHER

  • CES University

    lead OTHER

Principal Investigators

  • Ana M Herrera, PhD en Patología · CES University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2012-04-30

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412723 on ClinicalTrials.gov