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

Anemia Clinical Trial

Official title:

Nutritional Anemia: Prevention and Treatment in Early Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701246
• Other study ID #: FANUT 302004
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: March 12, 2014
• Start date: April 2005
• Est. completion date: March 2006

Study information

• Verified date: March 2014
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• ferrous sulfate

• folic acid

• placebo (folic acid)

Locations

Country	Name	City	State
Brazil	Universidade Federal de Goias	Goiânia	Goiás

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Federal University of São Paulo, Goiania Municipal Health Department, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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 Goiânia, Goiás State, Brazil: a randomized controlled trial. Cad Saude Publica. 2008;24 Suppl 2 — View 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. Erratum in: Lancet. 2006 Jan 28;367(9507):302. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Iron status		Approximately three months	No
Secondary	Prevalence of anemia		Approximately three months	No

External Links

•   Erratum of the title
•   Publication of the article