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Completed

NCT Number: NCT00701246

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

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.

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Key information

Conditions

Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Goias

Goiânia, Goiás, 74605-080, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate

Drug

Folic Acid

Drug

placebo (folic acid)

Drug

Primary outcomes

  1. Iron status

    Time frame: Approximately three months

Secondary outcomes

  1. Prevalence of anemia

    Time frame: Approximately three months

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Collaborators

  • Federal University of São Paulo
  • Goiania Municipal Health Department
  • Ministry of Health, Brazil

Registry information

Official study title

Nutritional Anemia: Prevention and Treatment in Early Childhood

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 19, 2008
Registry last updated
Mar 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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