Clinical trial NCT00701246: Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
Official title: Nutritional Anemia: Prevention and Treatment in Early Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Iron deficiency anemia
Infants
Children
Clinical trials
Ferrous sulfate
Folic acid
Daycare centers
Anaemia in children
born at term
non-twins
with parental approval for participation in the study
growth
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
name: Ministry of Health, Brazil
name: Goiania Municipal Health Department
First posted: 2008-06-19
Enrollment: 196
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Iron status
timeFrame: Approximately three months
Secondary outcomes:
measure: Prevalence of anemia
timeFrame: Approximately three months
Other outcomes:
measure: Linear ad weight gain of anemic and non-anemic
timeFrame: Approximately three months
Locations:
city: Goiânia
country: Brazil
facility: Universidade Federal de Goias
state: Goiás
Study officials:
affiliation: Universidade Federal de Goias
name: Maria Claret CM Hadler, PhD Sciences
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Dirce M Sigulem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias
name: Maria de Fátima C Alves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vila São José Bento Cotolengo
name: Vinícius M Torres, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nutrition of Federal University of Goias
name: Daniela AM Dias, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nutrition - Federal University of Goias
name: Andréa Sugai, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Hadler MC, Juliano Y, Sigulem DM. [Anemia in infancy: etiology and prevalence]. J Pediatr (Rio J). 2002 Jul-Aug;78(4):321-6. Portuguese.
citation: 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.
citation: 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.
citation: 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.
citation: 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.