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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-02

Study Completion Date

2018-10-30

Brief Summary

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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

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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.

Conditions

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Iron Deficiency Anemia

Keywords

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Iron Iron Deficiency Anemia Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL