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

NCT ID: NCT02076828

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fe-OH-PM (Santafer® sp.)(Group II)

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

Group Type: EXPERIMENTAL

Santafer® sp.

Intervention Type: DRUG

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.

Fe-Zn (Ferro Zinc® sp.)(Group III)

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

Group Type: EXPERIMENTAL

Ferro Zinc® sp

Intervention Type: DRUG

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.

Fe-S (Ferro Sanol® sp.)(Group I)

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

Group Type: EXPERIMENTAL

Ferro Sanol® sp

Intervention Type: DRUG

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.

Interventions

Ferro Sanol® sp

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

Santafer® sp.

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

Ferro Zinc® sp

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.

Intervention Type: DRUG

Other Intervention Names

Fe-S (Ferro Sanol® sp)(Group I); Fe-OH-PM (Santafer® sp.)(Group II); Fe-Zn (Ferro Zinc® sp.)(Group III)

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

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 180 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Ozsurekci

Pediatric Infectious Diseases Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Ozsurekci, MD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, Ankara/Sihhiye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HacettepeU

Identifier Type: -

Identifier Source: org_study_id