Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
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ClinicalTrials.gov Identifier: NCT00992823 |
Recruitment Status
:
Completed
First Posted
: October 9, 2009
Last Update Posted
: October 15, 2009
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Anemia | Drug: iron supplementation Biological: iron supplementation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
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.
|
- Initial and final blood hemoglobin concentration [ Time Frame: 10 months ]

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Ages Eligible for Study: | 24 Months to 59 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992823
Brazil | |
Public Day Care Centers | |
Badi Bassit, Sao Paulo, Brazil |
Study Director: | Patricia M Cury, MDPhD | FAMEP | |
Principal Investigator: | Geraldo PL Coutinho, MD | Sao Jose do Rio Preto Medical School |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | October 9, 2009 Key Record Dates |
Last Update Posted: | October 15, 2009 |
Last Verified: | October 2009 |
Keywords provided by Sao Jose do Rio Preto Medical School:
Iron anemia supplementation |
preschoolers prevalence preschoolers children from public day care centers |
Additional relevant MeSH terms:
Anemia Hematologic Diseases Iron Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs |