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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076828
• Other study ID #: HacettepeU
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 28, 2014
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2014
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 180 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Ankara/Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvements of the symptoms		2 Months	No
Primary	Change from baseline in Hb levels at 2 months		2 months	No
Secondary	Change from baseline in Iron levels at 2 months.		2 Months	No