Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate

University of Palermo

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Dietary Supplement: Lipofer®; Dietary Supplement: SunActive®Fe; Dietary Supplement: Intravenous ferric gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT03771092

CREAM-IRON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of iron deficiency anemia, microcytic and hypochromic
• Age >18

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 5 patient groups

Patients with non-severe anemia treated with SunActive®Fe

Experimental group

Description:

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

Treatment:

Dietary Supplement: SunActive®Fe

Patients with non-severe anemia treated with Lipofer®

Experimental group

Description:

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®

Treatment:

Dietary Supplement: Lipofer®

Patients with severe anemia with Lipofer®

Experimental group

Description:

Patients with severe anemia (Hb \<10 g/dl) treated respectively with Lipofer®

Treatment:

Dietary Supplement: Lipofer®

Patients with severe anemia with SunActive®Fe

Experimental group

Description:

Patients with severe anemia (Hb \<10 g/dl) treated respectively with SunActive®Fe micronized

Treatment:

Dietary Supplement: SunActive®Fe

Patients with severe anemia with intravenous ferric gluconate

Experimental group

Description:

Patients with severe anemia (Hb \<10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols

Treatment:

Dietary Supplement: Intravenous ferric gluconate