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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Dietary supplement: SunActive®Fe; Dietary supplement: Lipofer®; Dietary supplement: Intravenous ferric gluconate

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with non-severe anemia treated with SunActive®Fe; 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	Dietary supplement: SunActive®Fe; 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.
Experimental: Patients with non-severe anemia treated with 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®	Dietary supplement: Lipofer®; Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.
Experimental: Patients with severe anemia with Lipofer®; Patients with severe anemia (Hb <10 g/dl) treated respectively with Lipofer®	Dietary supplement: Lipofer®; Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.
Experimental: Patients with severe anemia with SunActive®Fe; Patients with severe anemia (Hb <10 g/dl) treated respectively with SunActive®Fe micronized	Dietary supplement: SunActive®Fe; 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.
Experimental: Patients with severe anemia with intravenous ferric gluconate; Patients with severe anemia (Hb <10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols	Dietary supplement: Intravenous ferric gluconate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HB	Mean change of hemoglobin concentration at three months	Three months

Collaborators and Investigators

• Sponsor: University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2015
• Primary Completion (Actual): May 30, 2016
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Anemia; Iron; Iron Deficiency Anemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Hematinics; Ferric gluconate
• Other Study ID Numbers: CREAM-IRON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No