Ferrous Sulfate Versus Iron Amino Acid Chelate

Condition(s) targeted: Iron Deficiency

Intervention: Ferrous sulfate as dietary supplementation (Other); Iron amino acid chelated as dietary supplementation (Other)

Phase: Phase 3

Status: Completed

Sponsored by: CES University

Official(s) and/or principal investigator(s):
Ana M Herrera, PhD en Patología, Study Director, Affiliation: CES University

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.

Official title: EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.

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

Primary outcome: Ferritin

Secondary outcome:

Hemoglobin

Infection

Adverse reaction

Minimum age: 2 Years. Maximum age: 5 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 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)

Exclusion Criteria: Children who

- Submit anemia (hemoglobin level equal to or less than 11 g/dL)

- Have not stool analysis before intervention

Universidad CES, Medellin, Antioquia, Colombia

Starting date: October 2011
Last updated: April 10, 2012