Iron-Deficiency Anemia in Infants in Two Weekly Programs

Study Overview
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Brief Summary
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This work aims at establishing the effectiveness of weekly doses of ferrous sulfate administered by mothers compared with weekly supplements administered directly by healthcare professionals, to reducing anemia prevalence.

Detailed Description
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Some studies have shown satisfactory results in reducing the prevalence of iron deficiency using weekly doses of ferrous sulfate, thereby avoiding these side effects. This deficiency is the most common nutritional disorder during childhood and does not only affect individuals from developing countries but also those from industrialized nations. For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency. In this age range the prevalence of anemia is at least 20%. However, studies have shown a low rate of compliance by mothers during the recommended period, which may be caused by a lack of care or, more probably, due to the side effects caused by long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea, staining of teeth and abdominal pain. This specific study is randomized clinical trial study, achieved in a government healthcare clinic in Sao Jose do Rio Preto, Sao Paulo, Brazil. This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron, either administered in the government healthcare clinic or at the children's home. The study showed treatment compliance in both groups. Prevalence of anemia for all children was 75% at the beginning of supplementation and 46.3% at the end of the period (p < 0.0005). Reduction rate for anemic children was 38.3%. Average increases in hemoglobin concentration levels were 0.75 g/dL and 0.65 g/dL, respectively, for home interventions and healthcare clinic administration (p < 0.00005).

Official Title
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Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs

Conditions
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Anemia

Intervention / Treatment
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* Drug: elemental iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages ranging between six and 24 months old Exclusion Criteria: Positive results for the Guthrie test Use of ferrous sulfate supplements Infections process at the time of first consultation

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>For infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency.This study was carried out using two intervention groups. All children received 12 weekly doses of 25 mg of elemental iron. Group 1 administered in the government healthcare clinic. Group 2 administered children's home. The study showed treatment compliance in both groups. | Drug: elemental iron<br>* Iron supplementation.<br>* Other names: doses of 25 mg of elemental iron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test (serum hemoglobin) |  | assessed at the before of the treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test (serum hemoglobin) |  | assessed after 12 weekly with iron supplement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Prevalence, Iron, Deficiency, Treatment