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Trial record 50 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT03771092
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Salvatore Corrao, MD, 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Dietary Supplement: SunActive®Fe Dietary Supplement: Lipofer® Dietary Supplement: Intravenous ferric gluconate Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CONTROLLED RANDOMIZED PILOT STUDY TO COMPARE THE EFFICACY OF DIFFERENT IRON FORMULATIONS: SUCROSOMAL FERRIC PYROPHOSPHATE, SUNACTIVE Fe AND INTRAVENOUS FERRIC GLUCONATE
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : May 30, 2016
Actual Study Completion Date : October 30, 2018


Arm Intervention/treatment
Experimental: 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
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.

Experimental: Patients with non-severe anemia treated with 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®
Dietary Supplement: Lipofer®
Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.

Experimental: Patients with severe anemia with Lipofer®
Patients with severe anemia (Hb <10 g/dl) treated respectively with Lipofer®
Dietary Supplement: Lipofer®
Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.

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

Experimental: Patients with severe anemia with intravenous ferric gluconate
Patients with severe anemia (Hb <10 g/dl) treated respectively with intravenous ferric gluconate according to departmental protocols
Dietary Supplement: 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.




Primary Outcome Measures :
  1. HB [ Time Frame: Three months ]
    Mean change of hemoglobin concentration at three months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Salvatore Corrao, MD, Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT03771092     History of Changes
Other Study ID Numbers: CREAM-IRON
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salvatore Corrao, MD, University of Palermo:
Iron
Iron Deficiency Anemia
Anemia
Additional relevant MeSH terms:
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Ferric gluconate
Ferric Compounds
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics