Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil

Study Overview
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Brief Summary
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Iron deficiency anemia is the most common nutritional problem in the world. The objectives of this study are: to evaluate the prevalence of anemia in children from 6 to 24 months of age and the therapeutic and prophylactic response to ferrous sulfate plus folic acid on hemoglobin levels. to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic Study hypothesis: The ferrous sulfate plus folic acid can improve the response on hemoglobin levels. The folic acid supplementation with ferrous sulfate have effect on the linear and weight growth of anemic and non-anemic.

Detailed Description
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Purpose The objective of this study were: to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. to compare the effect of folic acid supplementation with ferrous sulfate on the linear and weight growth of anemic and non-anemic. A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goias State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50μg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50μg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months.

Official Title
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Nutritional Anemia: Prevention and Treatment in Early Childhood

Conditions
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Anemia

Intervention / Treatment
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* Drug: ferrous sulfate
* Drug: folic acid
* Drug: placebo (folic acid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: from 6 to 24 months born at term non-twins with parental approval for participation in the study attending municipal daycare centers with mor than four children each Exclusion Criteria: Children with special needs low birth weight (<2.500g) with growth-impairing heart diseases neurological syndromes sickle-cell anemia sickle-cell trait under treatment for anemia at the time of the first interview or screening performed by the pediatrician those no longer attending the daycare center the clinical trial excluded children with hemoglobin >=7 amd <=8g/dL. For the second objective: incomplete anthropometric surveys

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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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg) | Drug: ferrous sulfate<br> <br> Drug: folic acid<br> <br> |
| Placebo Comparator: II<br>II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo. | Drug: ferrous sulfate<br> <br> Drug: placebo (folic acid)<br> <br> |
| Experimental: III<br>Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid | Drug: ferrous sulfate<br> <br> Drug: folic acid<br> <br> |
| Placebo Comparator: IV<br>1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week. | Drug: ferrous sulfate<br> <br> Drug: placebo (folic acid)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron status |  | Approximately three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anemia |  | Approximately three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron deficiency anemia, Infants, Children, Clinical trials, Ferrous sulfate, Folic acid, Daycare centers, Anaemia in children, born at term, non-twins, with parental approval for participation in the study, growth