Skip to main content
OpenTrials
Completed

NCT Number: NCT00992823

Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia.

Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

24 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Day Care Centers

Badi Bassit, São Paulo, Brazil

About this study

The prevalence of anemia after the supplementation regimens reduced from 20.20% to 5.05% (P < 0.0005); the reduction was not significantly different between the two groups (P = 0.35). The mean hemoglobin concentration increased in both groups (Group 1: 0.27 g/dL; P < 0.016 and Group 2: 0.47 g/dL; P < 0.0005) without significant differences between the groups (P = 0.17).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The participants of the study were children with ages ranging from 24 to 59 months old that attended four local public day care centers

Exclusion criteria

  • Presence of infection or reported infections within two weeks prior to the intervention
  • Anemia lower than 7.0 g/dL and children taking medications containing ferrous sulfate

Treatment and study plan

iron supplementation

Drug

40 doses of 30 mg of ferrous sulfate during a 10-month intervention period

iron supplementation

Biological

supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

Primary outcomes

  1. Initial and final blood hemoglobin concentration

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Sao Jose do Rio Preto Medical School

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Oct 9, 2009
Registry last updated
Oct 15, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.