Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil - Full Text View

Sponsors and Collaborators:	Universidade Federal de Goias Federal University of São Paulo Brazilian Ministry of Health Goiania Municipal Health Department
Information provided by:	Universidade Federal de Goias
ClinicalTrials.gov Identifier:	NCT00701246

Purpose

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. Study hypothesis: The ferrous sulfate plus folic acid can improve the response on hemoglobin levels.

Condition	Intervention
Anemia	Drug: ferrous sulfate Drug: folic acid Drug: placebo (folic acid)

MedlinePlus related topics: Anemia

Drug Information available for: Folic acid Ferrous sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Nutritional Anemia: Prevention and Treatment in Early Childhood

Further study details as provided by Universidade Federal de Goias:

Primary Outcome Measures:

Iron status [ Time Frame: Approximately three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevalence of anemia [ Time Frame: Approximately three months ] [ Designated as safety issue: No ]

Enrollment:	196
Study Start Date:	April 2005
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)	Drug: ferrous sulfate Drug: folic acid
II: Placebo Comparator II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.	Drug: ferrous sulfate Drug: placebo (folic acid)
III: Experimental Prevention of anemia in non-anemic children ( 5 times a week)- 1,4 mg/kg/day of ferrous sulfate and folic acid	Drug: ferrous sulfate Drug: folic acid
IV: Placebo Comparator 1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.	Drug: ferrous sulfate Drug: placebo (folic acid)

Detailed Description:

Purpose

The objective of this study was to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid.

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, Goiás 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

Ages Eligible for Study:	6 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701246

Locations

Brazil, Goiás
Universiadade Federal de Goias
Goiânia, Goiás, Brazil, 74605-080

Sponsors and Collaborators

Universidade Federal de Goias

Federal University of São Paulo

Brazilian Ministry of Health

Goiania Municipal Health Department

Investigators

Principal Investigator:	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:	Vinícius M Torres, MD	Vila São José Bento Cotolengo

More Information

Additional Information:

Publication of the article This link exits the ClinicalTrials.gov site

Erratum of the title This link exits the ClinicalTrials.gov site

Publications:

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 Goiânia, Goiás State, Brazil: a randomized controlled trial. Cad Saude Publica. 2008;24 Suppl 2:S259-71.

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. No abstract available.

Allen LH, Rosado JL, Casterline JE, López P, Muñoz 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.

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.

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.

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. Erratum in: Lancet. 2006 Jan 28;367(9507):302.

Responsible Party:	Universiadade Federal de Goias ( Profa Maria Claret Costa Monteiro Hadler, PhD )
Study ID Numbers:	FANUT 302004
Study First Received:	June 18, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00701246 History of Changes
Health Authority:	Brazil: Ethics Committee

Keywords provided by Universidade Federal de Goias:

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

Study placed in the following topic categories:

Folic Acid
Vitamin B Complex
Hematinics
Hematologic Diseases
Vitamins

Anemia
Trace Elements
Micronutrients
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Folic Acid
Vitamin B Complex
Hematinics
Hematologic Diseases
Therapeutic Uses
Growth Substances

Vitamins
Hematologic Agents
Physiological Effects of Drugs
Anemia
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009