Anemia Clinical Trial
Official title:
Nutritional Anemia: Prevention and Treatment in Early Childhood
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
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