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

NCT03771092 | Completed DMC

• 1 other identifier: CREAM-IRON
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency Anemia

Keywords

Iron; Iron Deficiency Anemia; Anemia

Outcome Measures

Primary Outcomes (1)

• HB

  Mean change of hemoglobin concentration at three months

  Three months

Study Arms (5)

Patients with non-severe anemia treated with SunActive®Fe

EXPERIMENTAL

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

Patients with non-severe anemia treated with Lipofer®

EXPERIMENTAL

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®

Patients with severe anemia with Lipofer®

EXPERIMENTAL

Patients with severe anemia (Hb \<10 g/dl) treated respectively with Lipofer®

Dietary Supplement: Lipofer®

Patients with severe anemia with SunActive®Fe

EXPERIMENTAL

Patients with severe anemia (Hb \<10 g/dl) treated respectively with SunActive®Fe micronized

Dietary Supplement: SunActive®Fe

Patients with severe anemia with intravenous ferric gluconate

EXPERIMENTAL

Patients with severe anemia (Hb \<10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols

Dietary Supplement: Intravenous ferric gluconate

Interventions

SunActive®Fe DIETARY_SUPPLEMENT

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.

Patients with non-severe anemia treated with SunActive®Fe; Patients with severe anemia with SunActive®Fe

Lipofer® DIETARY_SUPPLEMENT

Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.

Patients with non-severe anemia treated with Lipofer®; Patients with severe anemia with Lipofer®

Intravenous ferric gluconate DIETARY_SUPPLEMENT

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.

Patients with severe anemia with intravenous ferric gluconate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of iron deficiency anemia, microcytic and hypochromic
• Age \>18

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: December 10, 2018
• Study Start: November 2, 2015
• Primary Completion: May 30, 2016
• Study Completion: October 30, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share