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

The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Santafer® sp.; Drug: Ferro Zinc® sp; Drug: Ferro Sanol® sp

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara/Sihhiye
    • Ankara, Ankara/Sihhiye, Turkey, 06100
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Fe-OH-PM (Santafer® sp.)(Group II)
Experimental: 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	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.; Other Names: Fe-Zn (Ferro Zinc® sp.)(Group III)
Experimental: Fe-S (Ferro Sanol® sp.)(Group I); The patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally	Drug: 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.; Other Names: Fe-S (Ferro Sanol® sp)(Group I)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Hb levels at 2 months	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Iron levels at 2 months.	2 Months

Other Outcome Measures

Outcome Measure	Time Frame
Improvements of the symptoms	2 Months

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Yasemin Ozsurekci, MD, Hacettepe University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): March 4, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: anemia; iron polymaltose complexes; iron zinc
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Trace Elements; Micronutrients; Glycine Agents; Glycine; Zinc
• Other Study ID Numbers: HacettepeU