NCT00701246

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

June 18, 2008

Last Update Submit

March 12, 2014

Conditions

Anemia

Keywords

AnemiaIron deficiency anemiaInfantsChildrenClinical trialsFerrous sulfateFolic acidDaycare centersAnaemia in childrenborn at termnon-twinswith parental approval for participation in the studygrowth

Outcome Measures

Primary Outcomes (1)

  • Iron status

    Approximately three months

Secondary Outcomes (1)

  • Prevalence of anemia

    Approximately three months

Other Outcomes (1)

  • Linear ad weight gain of anemic and non-anemic

    Approximately three months

Study Arms (4)

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 sulfateDrug: 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 sulfateDrug: 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 sulfateDrug: folic acid

IV

PLACEBO COMPARATOR

1,4 mg/kg/day of ferrous sulfate plus folic acid placebo, five days a week.

Drug: ferrous sulfateDrug: placebo (folic acid)

Interventions

ferrous sulfateDRUG
IIIIIIIV
folic acidDRUG
IIII
placebo (folic acid)DRUG
IIIV

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Goias

Goiânia, Goiás, 74605-080, Brazil

Location

Related Publications (7)

  • 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.

    PMID: 12916807BACKGROUND

  • 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.

    PMID: 10837289BACKGROUND

  • Hadler MC, Juliano Y, Sigulem DM. [Anemia in infancy: etiology and prevalence]. J Pediatr (Rio J). 2002 Jul-Aug;78(4):321-6. Portuguese.

    PMID: 14647764BACKGROUND

  • 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.

    PMID: 15351537BACKGROUND

  • 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.

    PMID: 15231912BACKGROUND

  • 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.

    PMID: 16413877BACKGROUND

  • 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.

    PMID: 18670706RESULT

Related Links

MeSH Terms

Conditions

AnemiaAnemia, Iron-Deficiency

Interventions

ferrous sulfateFolic Acid

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesAnemia, HypochromicIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

April 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

BR(1)