Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
1 other identifier
interventional
99
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedOctober 15, 2009
October 1, 2009
11 months
October 8, 2009
October 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Initial and final blood hemoglobin concentration
10 months
Study Arms (2)
Group 1:iron weekly supplementation
ACTIVE COMPARATORGroup 2: cycle supplementation
ACTIVE COMPARATORtwo 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.
Interventions
40 doses of 30 mg of ferrous sulfate during a 10-month intervention period
Eligibility Criteria
You may qualify if:
- The participants of the study were children with ages ranging from 24 to 59 months old that attended four local public day care centers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public Day Care Centers
Badi Bassit, São Paulo, Brazil
Related Publications (1)
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.
PMID: 23305566DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patricia M Cury, MDPhD
FAMEP
- PRINCIPAL INVESTIGATOR
Geraldo PL Coutinho, MD
Sao Jose do Rio Preto Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 8, 2009
First Posted
October 9, 2009
Study Start
March 1, 2006
Primary Completion
February 1, 2007
Study Completion
July 1, 2008
Last Updated
October 15, 2009
Record last verified: 2009-10