Ferrous Sulfate Versus Iron Amino Acid Chelate

Study Overview
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Brief Summary
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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
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EFICACIA DEL HIERRO AMINOQUELADO COMPARADO CON EL SULFATO FERROSO COMO COMPLEMENTO ALIMENTARIO EN PREESCOLARES CON DEFICIENCIA DE HIERRO.

Conditions
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Iron Deficiency

Intervention / Treatment
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* Other: Ferrous sulfate as dietary supplementation
* Other: Iron amino acid chelated as dietary supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferrous sulphate<br>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<br>* Ferrous sulfate as dietary supplementation<br>|
| Experimental: Iron Amino acid chelate<br>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<br>* Iron amino acid chelated as dietary supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 8 weeks | 
| Infection | Daily written report of the caregiver during the intervention | 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. | Daily. During 2 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron Deficiency, Child, Preschool, Dietary Iron, Ferrous sulfate, Bis-glycino iron II