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

This study has been completed.
Sponsor:
Collaborators:
Federal University of São Paulo
Ministry of Health, Brazil
Goiania Municipal Health Department
Information provided by (Responsible Party):
Maria Claret Costa Monteiro Hadler, Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT00701246
First received: June 18, 2008
Last updated: March 12, 2014
Last verified: March 2014
  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.
  • 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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Nutritional Anemia: Prevention and Treatment in Early Childhood

Resource links provided by NLM:


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 ]

Other Outcome Measures:
  • Linear ad weight gain of anemic and non-anemic [ Time Frame: Approximately three months ] [ Designated as safety issue: No ]
    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)


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
Experimental: I
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
Placebo Comparator: II
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)
Experimental: III
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
Placebo Comparator: IV
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 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.

  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.
  • For the second objective: incomplete anthropometric surveys
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701246

Locations
Brazil
Universidade Federal de Goias
Goiânia, Goiás, Brazil, 74605-080
Sponsors and Collaborators
Universidade Federal de Goias
Federal University of São Paulo
Ministry of Health, Brazil
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
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
  More Information

Additional Information:
Publications:

Responsible Party: Maria Claret Costa Monteiro Hadler, PhD., Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT00701246     History of Changes
Other Study ID Numbers: FANUT 302004
Study First Received: June 18, 2008
Last Updated: March 12, 2014
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
growth

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014