Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
Longer than P75 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
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedMarch 4, 2014
February 1, 2014
1.2 years
February 25, 2014
February 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Hb levels at 2 months
2 months
Secondary Outcomes (1)
Change from baseline in Iron levels at 2 months.
2 Months
Other Outcomes (1)
Improvements of the symptoms
2 Months
Study Arms (3)
Fe-OH-PM (Santafer® sp.)(Group II)
EXPERIMENTALThe patients in Group II were treated with Fe-OH-PM (Santafer® sp.), 6 mg/kg/day orally.
Fe-Zn (Ferro Zinc® sp.)(Group III)
EXPERIMENTALThe patients in Group III were treated with Fe-Zn (Ferro Zinc® sp.), 6 mg/kg/day orally
Fe-S (Ferro Sanol® sp.)(Group I)
EXPERIMENTALThe patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally
Interventions
The children with IDA that included in Fe-S (Ferro Sanol® sp.)(Group I) were treated with a therapeutic dose Ferro Sanol® sp as 6 mg/kg/day in the first 2 months and followed by maintenance treatment at a dosage of 2 mg/kg/day for the next 2 months.
The children with IDA that included in Fe-OH-PM (Santafer® sp.)(Group II) were treated with a therapeutic dose Santafer® as 6 mg/kg/day in the first 2 months and followed by maintenance treatment at a dosage of 2 mg/kg/day for the next 2 months.
The children with IDA that included in Fe-Zn (Ferro Zinc® sp.)(Group III) were treated with a therapeutic dose Ferro Zinc® sp. as 6 mg/kg/day in the first 2 months and followed by maintenance treatment at a dosage of 2 mg/kg/day for the next 2 months.
Eligibility Criteria
You may qualify if:
- The children with IDA, aged between 6 months and 15 years, were randomly included in Fe-S (Ferro Sanol® sp.)(Group I), Fe-OH-PM (Santafer® sp.)(Group II), and Fe-Zn (Ferro Zinc® sp.)(Group III). IDA was defined as hemoglobin (Hgb), serum iron and ferritin levels below -2SD according to age and gender.
You may not qualify if:
- Severe concurrent illness (cardiovascular, renal, and hepatic)
- Known hypersensitivity to ferrous or ferric preparations
- Malignancy of any type
- Children with thalassemia major, sickle cell anemia or other hemoglobinopathies, hemolytic anemia or aplastic or hypoplastic anemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Ankara/Sihhiye, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasemin Ozsurekci, MD
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Infectious Diseases Specialist
Study Record Dates
First Submitted
February 25, 2014
First Posted
March 4, 2014
Study Start
January 1, 2008
Primary Completion
March 1, 2009
Study Completion
December 1, 2011
Last Updated
March 4, 2014
Record last verified: 2014-02