Clinical trial NCT02076828: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: anemia
iron polymaltose complexes
iron zinc
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in Hb levels at 2 months
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline in Iron levels at 2 months.
timeFrame: 2 Months
Other outcomes:
measure: Improvements of the symptoms
timeFrame: 2 Months
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Ankara/Sihhiye
Study officials:
affiliation: Hacettepe University
name: Yasemin Ozsurekci, MD
role: PRINCIPAL_INVESTIGATOR
References: