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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT00701246
Study type Interventional
Source Universidade Federal de Goias
Contact
Status Completed
Phase N/A
Start date April 2005
Completion date March 2006

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