Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
NCT ID: NCT00701246
Last Updated: 2014-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
196 participants
INTERVENTIONAL
2005-04-30
2006-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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I
I Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg)
ferrous sulfate
folic acid
II
II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.
ferrous sulfate
placebo (folic acid)
III
Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid
ferrous sulfate
folic acid
IV
1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.
ferrous sulfate
placebo (folic acid)
Interventions
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ferrous sulfate
folic acid
placebo (folic acid)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
24 Months
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Ministry of Health, Brazil
OTHER_GOV
Goiania Municipal Health Department
UNKNOWN
Universidade Federal de Goias
OTHER
Responsible Party
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Maria Claret Costa Monteiro Hadler
PhD.
Principal Investigators
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Maria Claret CM Hadler, PhD Sciences
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de Goias
Dirce M Sigulem, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Maria de Fátima C Alves, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de Goias
Vinícius M Torres, MD
Role: PRINCIPAL_INVESTIGATOR
Vila São José Bento Cotolengo
Daniela AM Dias, MSc.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Nutrition of Federal University of Goias
Andréa Sugai, PhD.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Nutrition - Federal University of Goias
Locations
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Universidade Federal de Goias
Goiânia, Goiás, Brazil
Countries
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References
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Wieringa FT, Dijkhuizen MA, van der Ven-Jongekrijg J, West CE, Muhilal, van der Meer JW. Micronutrient deficiency and supplementation in Indonesian infants. Effects on immune function. Adv Exp Med Biol. 2003;531:369-77. doi: 10.1007/978-1-4615-0059-9_31. No abstract available.
Allen LH, Rosado JL, Casterline JE, Lopez P, Munoz E, Garcia OP, Martinez H. Lack of hemoglobin response to iron supplementation in anemic mexican preschoolers with multiple micronutrient deficiencies. Am J Clin Nutr. 2000 Jun;71(6):1485-94. doi: 10.1093/ajcn/71.6.1485.
Hadler MC, Juliano Y, Sigulem DM. [Anemia in infancy: etiology and prevalence]. J Pediatr (Rio J). 2002 Jul-Aug;78(4):321-6. Portuguese.
Hadler MC, Colugnati FA, Sigulem DM. Risks of anemia in infants according to dietary iron density and weight gain rate. Prev Med. 2004 Oct;39(4):713-21. doi: 10.1016/j.ypmed.2004.02.040.
Geltman PL, Meyers AF, Mehta SD, Brugnara C, Villon I, Wu YA, Bauchner H. Daily multivitamins with iron to prevent anemia in high-risk infants: a randomized clinical trial. Pediatrics. 2004 Jul;114(1):86-93. doi: 10.1542/peds.114.1.86.
Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):133-43. doi: 10.1016/S0140-6736(06)67962-2.
Hadler MC, Sigulem DM, Alves Mde F, Torres VM. Treatment and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiania, Goias State, Brazil: a randomized controlled trial. Cad Saude Publica. 2008;24 Suppl 2:S259-71. doi: 10.1590/s0102-311x2008001400011.
Related Links
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Publication of the article
Erratum of the title
Other Identifiers
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FANUT 302004
Identifier Type: -
Identifier Source: org_study_id
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