Therapeutic and Prophylactic Effect of Ferrous Sulfate Plus Folic Acid in Children in Goiania, Brazil - Full Text View

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 Folic Acid	Drug: ferrous sulfate and folic acid Drug: placebo

MedlinePlus related topics:

Anemia

Drug Information available for:

Folic acid Ferrous sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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 Universiadade 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 and folic acid Treatment: a daily dose (5 times a week) of either 4,2 mg/kg/day of ferrous sulfate + folic acid (50 mcg) days a week.
II: Placebo Comparator II Treatment of anemic children with 4,2 mg/kg/day of ferrous sulfate and folic acid placebo.	Drug: placebo 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	Drug: ferrous sulfate and folic acid 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.	Drug: placebo 1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.

Detailed Description:

Purpose

The objective of this study are 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 are being conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goiás State, Brazil. The children will be assigned to two treatment groups that will receive 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 will receive 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 will last last 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

Universiadade 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	Universiadade Federal de Goias

Principal Investigator:	Dirce M Sigulem, MD, PhD	Federal University of São Paulo

Principal Investigator:	Maria de Fátima C Alves, PhD	Universiadade Federal de Goias

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

More Information

Publications:

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
First Received:	June 18, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00701246
Health Authority:	Brazil: Ethics Committee

Keywords provided by Universiadade 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

Hematologic Diseases

Anemia

Iron

Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Vitamin B Complex

Hematinics

Therapeutic Uses

Growth Substances

Vitamins

Hematologic Agents

Physiological Effects of Drugs

Micronutrients

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

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