Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure - Full Text View

Purpose

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.

Condition	Intervention
Anemia	Drug: iron supplementation Biological: iron supplementation


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron Toddler Health

U.S. FDA Resources

Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:

Initial and final blood hemoglobin concentration [ Time Frame: 10 months ] [ Designated as safety issue: No ]


Enrollment:	99
Study Start Date:	March 2006
Study Completion Date:	July 2008
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group 1:iron weekly supplementation	Drug: iron supplementation 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period
Active Comparator: Group 2: cycle supplementation two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.	Biological: iron supplementation supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

Detailed 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).

Eligibility


Ages Eligible for Study:	24 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00992823

Locations


Brazil
Public Day Care Centers
Badi Bassit, Sao Paulo, Brazil

Sponsors and Collaborators

Sao Jose do Rio Preto University

Investigators


Study Director:	Patricia M Cury, MDPhD	FAMEP
Principal Investigator:	Geraldo PL Coutinho, MD	Sao Jose do Rio Preto University

More Information

No publications provided by Sao Jose do Rio Preto University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Coutinho GG, Cury PM, Cordeiro JA. Cyclical iron supplementation to reduce anemia among Brazilian preschoolers: a randomized controlled trial. BMC Public Health. 2013 Jan 10;13:21. doi: 10.1186/1471-2458-13-21.


Responsible Party:	Geraldo Gaspar Paes Leme Coutinho, Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:	NCT00992823 History of Changes
Other Study ID Numbers:	0708/2006
Study First Received:	October 8, 2009
Last Updated:	October 14, 2009
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Sao Jose do Rio Preto University:


Iron anemia supplementation	preschoolers prevalence preschoolers children from public day care centers

Additional relevant MeSH terms:


Iron Growth Substances Micronutrients	Pharmacologic Actions Physiological Effects of Drugs Trace Elements

ClinicalTrials.gov processed this record on March 03, 2015