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

S

Sao Jose do Rio Preto Medical School

Status

Completed

Conditions

Anemia

Treatments

Biological: iron supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT00992823
0708/2006

Details and patient eligibility

About

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.

Full description

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).

Enrollment

99 patients

Sex

All

Ages

24 to 59 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

99 participants in 2 patient groups

Group 1:iron weekly supplementation
Active Comparator group
Group 2: cycle supplementation
Active Comparator group
Description:
two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
Treatment:
Biological: iron supplementation
Biological: iron supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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