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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771092
• Other study ID #: CREAM-IRON
• Status: Completed
• Phase: N/A
• Start date: November 2, 2015
• Est. completion date: October 30, 2018

Study information

• Verified date: December 2018
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: October 30, 2018
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

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.
• Lipofer®
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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HB	Mean change of hemoglobin concentration at three months	Three months