Iron Deficiency AnemiaNCT03771092
Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate
A study testing SunActive®Fe, Lipofer® and Intravenous ferric gluconate in people with Iron Deficiency Anemia, run by University of Palermo.
Trial summary
The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- SunActive®Fe, Lipofer® and Intravenous ferric gluconate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 30 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of iron deficiency anemia, microcytic and hypochromic
- Age >18
Who cannot join
- Diagnosis of Celiac Disease
- Patients who refuse to sign the informed consent
- Clinically relevant cognitive Turbe
- Hemodynamic instability defined by the presence of low blood pressure SBP <100 FC> 100
- Dyspnea after modest effort worsening over the past 10 days
- Oxygen peripheral saturation values <94%
- Ischemic heart Recent and / or lower limbs
- Acute conditions with subacute or at recruitment
About this study
Official title: CONTROLLED RANDOMIZED PILOT STUDY TO COMPARE THE EFFICACY OF DIFFERENT IRON FORMULATIONS: SUCROSOMAL FERRIC PYROPHOSPHATE, SUNACTIVE Fe AND INTRAVENOUS FERRIC GLUCONATE
The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.
Read the detailed description
Background: Iron deficiency anemia (IDA) still remains universally a worldwide problematics. Anemia is defined as a hemoglobin value <12.0 g/dL (7.45 mmol/L). Management of IDA is based on martial iron supplementation. The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.
Trial Design, Methods and Findings: Clinical data from 106 outpatients (82.8% female and 17.2% male, mean age 50.4 years) were collected at Department of Internal Medicine, National Relevance and High Specialization Hospital Trust, ARNAS Civico-Di Cristina-Benfratelli, Palermo, Italy. The study envisaged five arms (2 + 3). At the first two arms were assigned patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with SunActive®Fe micronized or Lipofer®. At the other three arms were assigned patients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized, Lipofer® or with intravenous ferric gluconate infusions according to departmental protocols. The followed methodology is defined in the PROBE project (acronym of Prospective Randomized Open Blinded End-point). The end points will be blinded with respect to the three treatments, as it will be the statistical analysis.
- Conditions
- Iron Deficiency Anemia
- Being tested
- SunActive®Fe, Lipofer®, Intravenous ferric gluconate
- Keywords
- Iron, Iron Deficiency Anemia, Anemia
- 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.
SunActive®FeDietary supplement
SunActive® Fe is a colorless, odorless, tasteless iron fortifier in a powder form. This product is most commonly used to increase the amount of iron in food, beverage, and dietary supplement applications.
Lipofer®Dietary supplement
Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.
Intravenous ferric gluconateDietary supplement
Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 - 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate.
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-severe anemia treated with SunActive®Fe | Experimental | Patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with SunActive®Fe micronized Receives: Dietary Supplement: SunActive®Fe |
| Patients with non-severe anemia treated with Lipofer® | Experimental | Patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with Lipofer® Receives: Dietary Supplement: Lipofer® |
| Patients with severe anemia with Lipofer® | Experimental | Patients with severe anemia (Hb <10 g/dl) treated respectively with Lipofer® Receives: Dietary Supplement: Lipofer® |
| Patients with severe anemia with SunActive®Fe | Experimental | Patients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized Receives: Dietary Supplement: SunActive®Fe |
| Patients with severe anemia with intravenous ferric gluconate | Experimental | Patients with severe anemia (Hb <10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols Receives: Dietary Supplement: Intravenous ferric gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HB
Mean change of hemoglobin concentration at three months
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start2 Nov 2015
- Primary completion30 May 2016
- Study completion30 Oct 2018
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Corrao, MD, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771092
- Sponsor's protocol ID
- CREAM-IRON
- Status last verified
- Dec 2018
- First submitted
- 6 Nov 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTROLLED RANDOMIZED PILOT STUDY TO COMPARE THE EFFICACY OF DIFFERENT IRON FORMULATIONS: SUCROSOMAL FERRIC PYROPHOSPHATE, SUNACTIVE Fe AND INTRAVENOUS FERRIC GLUCONATE
- ClinicalTrials.gov ID
- NCT03771092
- Acronym / sponsor ID
- CREAM-IRON
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron, Iron Deficiency Anemia, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 10 Dec 2018 (actual)
- 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 purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.
Detailed description
Background: Iron deficiency anemia (IDA) still remains universally a worldwide problematics. Anemia is defined as a hemoglobin value <12.0 g/dL (7.45 mmol/L). Management of IDA is based on martial iron supplementation. The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.
Trial Design, Methods and Findings: Clinical data from 106 outpatients (82.8% female and 17.2% male, mean age 50.4 years) were collected at Department of Internal Medicine, National Relevance and High Specialization Hospital Trust, ARNAS Civico-Di Cristina-Benfratelli, Palermo, Italy. The study envisaged five arms (2 + 3). At the first two arms were assigned patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with SunActive®Fe micronized or Lipofer®. At the other three arms were assigned patients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized, Lipofer® or with intravenous ferric gluconate infusions according to departmental protocols. The followed methodology is defined in the PROBE project (acronym of Prospective Randomized Open Blinded End-point). The end points will be blinded with respect to the three treatments, as it will be the statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with non-severe anemia treated with SunActive®Fe | Experimental | Dietary Supplement: SunActive®FePatients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with SunActive®Fe micronized |
| Patients with non-severe anemia treated with Lipofer® | Experimental | Dietary Supplement: Lipofer®Patients with non-severe anemia Hb> 10 g/dl (Hb <12 g/dl for women and Hb <13 g/dl for men), treated with Lipofer® |
| Patients with severe anemia with Lipofer® | Experimental | Dietary Supplement: Lipofer®Patients with severe anemia (Hb <10 g/dl) treated respectively with Lipofer® |
| Patients with severe anemia with SunActive®Fe | Experimental | Dietary Supplement: SunActive®FePatients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized |
| Patients with severe anemia with intravenous ferric gluconate | Experimental | Dietary Supplement: Intravenous ferric gluconatePatients with severe anemia (Hb <10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of iron deficiency anemia, microcytic and hypochromic
- Age >18
Key exclusion criteria (8 listed)
- Diagnosis of Celiac Disease
- Patients who refuse to sign the informed consent
- Clinically relevant cognitive Turbe
- Hemodynamic instability defined by the presence of low blood pressure SBP <100 FC> 100
- Dyspnea after modest effort worsening over the past 10 days
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 |
|---|---|---|
| SunActive®FeSunActive® Fe is a colorless, odorless, tasteless iron fortifier in a powder form. This product is most commonly used to increase the amount of iron in food, beverage, and dietary supplement applications. | Dietary supplement | Patients with non-severe anemia treated with SunActive®Fe, Patients with severe anemia with SunActive®Fe |
| Lipofer®Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats. | Dietary supplement | Patients with non-severe anemia treated with Lipofer®, Patients with severe anemia with Lipofer® |
| Intravenous ferric gluconateSodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 - 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate. | Dietary supplement | Patients with severe anemia with intravenous ferric gluconate |
Primary outcome
HB
Time frame: Three months
Mean change of hemoglobin concentration at three 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 10 Dec 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SunActive®Fe, Lipofer® and Intravenous ferric gluconate in people with Iron Deficiency Anemia, run by University of Palermo.
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 2 inclusion and 8 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 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
HB (time frame: Three 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 10 Dec 2018.