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| Name | Class |
|---|---|
| Federal University of São Paulo | OTHER |
| Ministry of Health, Brazil | OTHER_GOV |
| Goiania Municipal Health Department | UNKNOWN |
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Iron deficiency anemia is the most common nutritional problem in the world.
The objectives of this study are:
Study hypothesis:
Purpose
The objective of this study were:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferrous sulfate | Drug |
| ||
| folic acid |
| Measure | Description | Time Frame |
|---|---|---|
| Iron status | Approximately three months |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of anemia | Approximately three months |
| Measure | Description | Time Frame |
|---|---|---|
| Linear ad weight gain of anemic and non-anemic | Linear and weight gain of anemic and non-anemic observed by anthropometric surveys (Z-score for weight-for-age, Z-score for height-for-age, Z-score for weight-for-height, average monthly weight, monthly length gain, and gain of Z-scores for weight-for-age, height-for-age, weight-for-height) | Approximately three months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Claret CM Hadler, PhD Sciences | Universidade Federal de Goias | Principal Investigator |
| Dirce M Sigulem, MD, PhD | Federal University of São Paulo | Principal Investigator |
| Maria de Fátima C Alves, PhD | Universidade Federal de Goias | Principal Investigator |
| VinÃcius M Torres, MD | Vila São José Bento Cotolengo | Principal Investigator |
| Daniela AM Dias, MSc. | Faculty of Nutrition of Federal University of Goias | Principal Investigator |
| Andréa Sugai, PhD. | Faculty of Nutrition - Federal University of Goias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Goias | Goiânia | Goiás | 74605-080 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12916807 | 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. | |
| 10837289 | 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. |
| Label | URL |
|---|---|
| Publication of the article | View source |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
|
| placebo (folic acid) | Drug |
|
| 14647764 | 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. |
| 15351537 | 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. |
| 15231912 | 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. |
| 16413877 | 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. |
| 18670706 | Result | 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. |
| Erratum of the title | View source |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |