Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate
- Conditions
- Iron Deficiency Anemia
- Interventions
- Dietary Supplement: Lipofer®Dietary Supplement: Intravenous ferric gluconateDietary Supplement: SunActive®Fe
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- Diagnosis of iron deficiency anemia, microcytic and hypochromic
- Age >18
- 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
- Arm && Interventions
Group Intervention Description Patients with non-severe anemia treated with Lipofer® 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® Patients with severe anemia with intravenous ferric gluconate Intravenous ferric gluconate Patients with severe anemia (Hb \<10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols Patients with severe anemia with Lipofer® Lipofer® Patients with severe anemia (Hb \<10 g/dl) treated respectively with Lipofer® Patients with severe anemia with SunActive®Fe SunActive®Fe Patients with severe anemia (Hb \<10 g/dl) treated respectively with SunActive®Fe micronized Patients with non-severe anemia treated with SunActive®Fe 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
- Primary Outcome Measures
Name Time Method HB Three months Mean change of hemoglobin concentration at three months
- Secondary Outcome Measures
Name Time Method