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

March 12, 2014 updated by: Maria Claret Costa Monteiro Hadler, Universidade Federal de Goias

Nutritional Anemia: Prevention and Treatment in Early Childhood

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-080
        • Universidade Federal de Goias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: folic acid
Drug: ferrous sulfate
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: folic acid
Drug: ferrous sulfate
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iron status
Time Frame: Approximately three months
Approximately three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of anemia
Time Frame: Approximately three months
Approximately three months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear ad weight gain of anemic and non-anemic
Time Frame: Approximately three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FANUT 302004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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