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

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia

• Registration Number: NCT03771092
• Lead Sponsor: University of Palermo

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.

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 Timeline

• Study Start: 2015-11-02
• Primary Completion: 2016-05-30
• Study Completion: 2018-10-30
• Study First Submitted: 2018-11-06
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-07
• Last Update Submitted: 2018-12-07
• Study First Posted: 2018-12-10
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HB	Three months	Mean change of hemoglobin concentration at three months