Iron Deficiency AnemiaNCT02076828
Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia
A study testing Ferro Sanol® sp, Santafer® sp. and Ferro Zinc® sp in people with Iron Deficiency Anemia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA. Read more about this study
- Who is it for?
- Ages 6 to 180 months
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferro Sanol® sp, Santafer® sp. and Ferro Zinc® sp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 180 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Ankara/Sihhiye, 06100
About this study
The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.
Read the 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
- Being tested
- Ferro Sanol® sp, Santafer® sp., Ferro Zinc® sp
- Keywords
- anemia, iron polymaltose complexes, iron zinc
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferro Sanol® spDrug
Also called Fe-S (Ferro Sanol® sp)(Group I)
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.Drug
Also called Fe-OH-PM (Santafer® sp.)(Group II)
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® spDrug
Also called Fe-Zn (Ferro Zinc® sp.)(Group III)
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.
| Study group | Role | What they receive |
|---|---|---|
| Fe-OH-PM (Santafer® sp.)(Group II) | Experimental | The patients in Group II were treated with Fe-OH-PM (Santafer® sp.), 6 mg/kg/day orally. Receives: Drug: Santafer® sp. |
| Fe-Zn (Ferro Zinc® sp.)(Group III) | Experimental | The patients in Group III were treated with Fe-Zn (Ferro Zinc® sp.), 6 mg/kg/day orally Receives: Drug: Ferro Zinc® sp |
| Fe-S (Ferro Sanol® sp.)(Group I) | Experimental | The patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally Receives: Drug: Ferro Sanol® sp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hb levels at 2 months
Measured: 2 months
Secondary outcomes (1)
Change from baseline in Iron levels at 2 months.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ozsurekci, Hacettepe University
- Investigators
- Yasemin Ozsurekci, MD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076828
- Sponsor's protocol ID
- HacettepeU
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT02076828
- Acronym / sponsor ID
- HacettepeU
- Conditions
- Iron Deficiency Anemia
- Keywords
- anemia, iron polymaltose complexes, iron zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fe-OH-PM (Santafer® sp.)(Group II) | Experimental | Drug: Santafer® sp.The patients in Group II were treated with Fe-OH-PM (Santafer® sp.), 6 mg/kg/day orally. |
| Fe-Zn (Ferro Zinc® sp.)(Group III) | Experimental | Drug: Ferro Zinc® spThe patients in Group III were treated with Fe-Zn (Ferro Zinc® sp.), 6 mg/kg/day orally |
| Fe-S (Ferro Sanol® sp.)(Group I) | Experimental | Drug: Ferro Sanol® spThe patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally |
Who may qualify
- Ages
- 6 to 180 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferro Sanol® spAlso: Fe-S (Ferro Sanol® sp)(Group I)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. | Drug | Fe-S (Ferro Sanol® sp.)(Group I) |
| Santafer® sp.Also: Fe-OH-PM (Santafer® sp.)(Group II)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. | Drug | Fe-OH-PM (Santafer® sp.)(Group II) |
| Ferro Zinc® spAlso: Fe-Zn (Ferro Zinc® sp.)(Group III)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. | Drug | Fe-Zn (Ferro Zinc® sp.)(Group III) |
Primary outcome
Change from baseline in Hb levels at 2 months
Time frame: 2 months
1 secondary outcome
Change from baseline in Iron levels at 2 months.
Time frame: 2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Ozsurekci, MD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferro Sanol® sp, Santafer® sp. and Ferro Zinc® sp in people with Iron Deficiency Anemia, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hb levels at 2 months (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.