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Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ferro Sanol® sp
Santafer® sp.
Ferro Zinc® sp
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring anemia, iron polymaltose complexes, iron zinc

Eligibility Criteria

6 Months - 180 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The main exclusion criteria were anemia due to other causes except IDA
  • 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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Fe-OH-PM (Santafer® sp.)(Group II)

Fe-Zn (Ferro Zinc® sp.)(Group III)

Fe-S (Ferro Sanol® sp.)(Group I)

Arm Description

The patients in Group II were treated with Fe-OH-PM (Santafer® sp.), 6 mg/kg/day orally.

The patients in Group III were treated with Fe-Zn (Ferro Zinc® sp.), 6 mg/kg/day orally

The patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally

Outcomes

Primary Outcome Measures

Change from baseline in Hb levels at 2 months

Secondary Outcome Measures

Change from baseline in Iron levels at 2 months.

Full Information

First Posted
February 25, 2014
Last Updated
February 28, 2014
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02076828
Brief Title
Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia
Official Title
Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.
Detailed Description
Iron deficiency (ID) is the most common cause of the anemia throughout the world, with almost half of the population in developing countries suffering from ID. Children with iron deficiency anemia (IDA) may have functional consequences including impaired motor and physical growth. In the case of IDA, the underlying cause should be identified and treated. Iron supplementation remains an important strategy for the prevention and treatment of IDA and can produce substantial improvements in the functional performance of iron deficient individuals. The iron-containing preparations available on the market vary widely in dosage, salt, and chemical state of iron (ferrous or ferric form). Current treatment strategy for IDA involves the oral use of Fe2+ salts (Fe SO4) and Fe3+ polymaltose complexes (FeOH3). Most of these preparations vary in their bioavailability, efficacy, side effects, and cost. Animal studies have not shown any significant difference in their oral bioavailability. However, in clinical practice, bivalent iron salts such as ferrous sulfate (Fe-S), ferrous gluconate, and ferrous fumarate are more widely used and are preferred over ferric iron preparations. Fe-S preparations usually present good bioavailability (between 10 and 15 %), while bioavailability of ferric iron preparations is 3 to 4 times less than that of conventional Fe-S. This is due to the extremely poor solubility of ferric iron in alkaline media and the fact that ferric iron needs to be transformed into ferrous iron before being absorbed. For this reason, among ferrous preparations, Fe-S remains the established and the standard treatment of ID due to its acceptable tolerability, high effectiveness, and low cost. The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
anemia, iron polymaltose complexes, iron zinc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fe-OH-PM (Santafer® sp.)(Group II)
Arm Type
Experimental
Arm Description
The patients in Group II were treated with Fe-OH-PM (Santafer® sp.), 6 mg/kg/day orally.
Arm Title
Fe-Zn (Ferro Zinc® sp.)(Group III)
Arm Type
Experimental
Arm Description
The patients in Group III were treated with Fe-Zn (Ferro Zinc® sp.), 6 mg/kg/day orally
Arm Title
Fe-S (Ferro Sanol® sp.)(Group I)
Arm Type
Experimental
Arm Description
The patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally
Intervention Type
Drug
Intervention Name(s)
Ferro Sanol® sp
Other Intervention Name(s)
Fe-S (Ferro Sanol® sp)(Group I)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Santafer® sp.
Other Intervention Name(s)
Fe-OH-PM (Santafer® sp.)(Group II)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferro Zinc® sp
Other Intervention Name(s)
Fe-Zn (Ferro Zinc® sp.)(Group III)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Hb levels at 2 months
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from baseline in Iron levels at 2 months.
Time Frame
2 Months
Other Pre-specified Outcome Measures:
Title
Improvements of the symptoms
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
180 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: The main exclusion criteria were anemia due to other causes except IDA 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Ozsurekci, MD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Ankara/Sihhiye
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia

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