Ferrous Sulfate Versus Iron Amino Acid Chelate

CES University

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency

Treatments: Other: Iron amino acid chelated as dietary supplementation; Other: Ferrous sulfate as dietary supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01412723

SFHA-01

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Ferrous sulphate

Active Comparator group

Description:

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

Treatment:

Other: Ferrous sulfate as dietary supplementation

Iron Amino acid chelate

Experimental group

Description:

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

Treatment:

Other: Iron amino acid chelated as dietary supplementation