drugset / Trial / NCT00701246
Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil
Completed
196 enrolled
Federal University of Goiás
Federal University of São Paulo · collabGoiania Municipal Health Department · collabMinistry of Health, Brazil · collab
RandomizedParallel-groupTriple-blind
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.
Timeline
- Start
- 2005-04
- Primary completion
- 2006-03
- Completion
- 2006-03
Publications
- Background 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.
- Background 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.
- Background Hadler MC, Juliano Y, Sigulem DM. [Anemia in infancy: etiology and prevalence]. J Pediatr (Rio J). 2002 Jul-Aug;78(4):321-6. Portuguese.
- Background 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.
- Background 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.
- Background 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferrous Sulfate | Diagnostic / imaging agent | 1.4 mg/kg | — |
| Subject | Ferrous Sulfate | Diagnostic / imaging agent | 4.2 mg/kg | — |
| Subject | folic acid | Other / unclassified | 50 ug | — |