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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014