Trial | NCT00701246  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    196
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.
Study Started
Apr 30
2005
Primary Completion
Mar 31
2006
Study Completion
Mar 31
2006
Last Update
Mar 13
2014
Estimate

Drug ferrous sulfate

Drug folic acid

Drug placebo (folic acid)

I Experimental

I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg)

II Placebo Comparator

II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.

III Experimental

Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid

IV Placebo Comparator

1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.

Criteria 

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
No Results Posted