Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
- Conditions
- Anemia
- Interventions
- Registration Number
- NCT00701246
- Lead Sponsor
- Universidade Federal de Goias
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I ferrous sulfate I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg) I folic acid I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg) II ferrous sulfate II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo. II placebo (folic acid) II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo. III ferrous sulfate Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid III folic acid Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid IV ferrous sulfate 1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week. IV placebo (folic acid) 1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.
- Primary Outcome Measures
Name Time Method Iron status Approximately three months
- Secondary Outcome Measures
Name Time Method Prevalence of anemia Approximately three months
Trial Locations
- Locations (1)
Universidade Federal de Goias
🇧🇷Goiânia, Goiás, Brazil