Ferrous Sulfate Versus Iron Amino Acid Chelate

CES University64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Iron Deficiency

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 8 weeks

Secondary Outcomes

Hemoglobin

The Hemoglobin level in blood will be measured at the beginning of the study as one of the most important exclusion criteria. 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) hemoglobin level will be measured again as one of secundary outcome measure. The hypothesis is that the hemoglobin level won't decrease

Time frame: Up to 8 weeks

Infection

Daily written report of the caregiver during the intervention

Time frame: Daily. During 2 months of intervention

Adverse reaction

The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea, vomiting, constipation, diarrhea, darkening of feces, and disgust for food.