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

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT03771092

Collaborator

(none)

148

Enrollment

Arms

35.9

Actual Duration (Months)

Study Details

Study Description

Brief 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 identified by the simultaneous presence of anemia, microcytosis and hypoferremia.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Dietary Supplement: SunActive®Fe Dietary Supplement: Lipofer® Dietary Supplement: Intravenous ferric gluconate	N/A

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

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

CONTROLLED RANDOMIZED PILOT STUDY TO COMPARE THE EFFICACY OF DIFFERENT IRON FORMULATIONS: SUCROSOMAL FERRIC PYROPHOSPHATE, SUNACTIVE Fe AND INTRAVENOUS FERRIC GLUCONATE

Actual Study Start Date :

Nov 2, 2015

Actual Primary Completion Date :

May 30, 2016

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

HB [Three months]
Mean change of hemoglobin concentration at three months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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