Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia (ACCESS)
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|ClinicalTrials.gov Identifier: NCT03524651|
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Drug: Ferrous Sulfate Drug: Fe-ASP||Phase 4|
Anemia is a major problem in the general population affecting 5.6% in the United States. Iron deficiency is the most common cause of anemia. Although traditionally considered to be mainly a problem of underdeveloped countries, a recent epidemiological survey reported high incidence of iron deficiency anemia (IDA) in Europe in 2011. The incidence rate measured per 1,000 person-years was 8.18 in Belgium, 8.93 in Italy, 12.42 in Germany and 14.14 in Spain. Women were affected four-times more than men. The major causes of IDA are chronic blood loss, chronic disorders and excess needs.
The cornerstones of management of IDA are recognition and management of the cause of iron loss and efficient iron supplementation. Iron supplementation is usually done through oral formulations of iron. Three oral iron preparations are broadly used: ferrous sulfate, ferrous gluconate, and ferrous fumarate. The usual dosage is 325 mg (corresponding to 65 mg of elemental iron) two times a day. One major limitation with oral iron supplementation is GI side effects observed in almost 40% of cases. These are gastric discomfort, nausea, vomiting and constipation and they are caused due to the oxidation of ferrous irons in the stomach by acidic gastric fluid into insoluble salts.
A new formulation of iron conjugated to one N-acetyl-aspartate derivative of casein (Fe-ASP) has recently been developed. Due to the casein coating, it is anticipated that iron is converted to a smaller extent in the stomach into insoluble salts. In this way, more iron reaches the duodenum to become absorbed whereas GI side effects are less often. In parallel, animal studies have shown that casein itself primes the expression of enzymes that facilitate the absorption of iron across the duodenal mucosa.
This formulation is anticipated to be better tolerated for oral ingestion since iron is readily absorbed in the duodenum. The aim is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with IDA for the restoration of decreased circulating Hb.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-dummy, blind, randomized, phase IV clinical trial|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind|
|Official Title:||Ferrous Acetyl-Aspartate Casein Formulation Evaluation Over Ferrous Sulfate in Iron Deficiency Anemia (ACCESS): A Double-Dummy Randomized Clinical Trial|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||March 1, 2019|
Active Comparator: Ferrous sulfate
Patients will take every day for 12 weeks two oral capsules of 150 mg ferrous sulfate delivering 47 mg of active elemental iron. Capsules should be taken orally either two hours before meal or two hours after meal. The same patients will take every day on exactly the same time for 12 weeks two placebo vials of 15 ml volume with excipients contained in the commercially available formulation Fe-Asp Omalin (Uni-Pharma SA).
Drug: Ferrous Sulfate
Blisters of 10 capsules containing 150 mg of ferrous sulfate.
Other Name: Microfer
Drug: Ferrous Sulfate
Boxes of 10 vials of 15 ml containing inactive ingredients of Omalin.
Other Name: Omalin placebo
Active Comparator: Fe-ASP
Patients will take every day for 12 weeks two oral placebo capsules. Capsules should be taken orally either two hours before meal or two hours after meal. The same patients will take every day on exactly the same time for 12 weeks two vials of 15 ml volume of the Fe-Asp preparation Omalin (Uni-Pharma SA) delivering 40 mg of elemental iron.
Boxes of 10 vials of 15 ml containing 800 mg of Iron protein acetyl aspartate.
Other Name: Omalin
Blisters of 10 capsules containing inactive ingredients of Microfer.
Other Name: Microfer placebo
- Comparative increase of baseline Hb [ Time Frame: 4 weeks ]The primary study endpoint is the comparative increase of baseline Hb in each study group after the first 4 weeks of treatment. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb will be adjusted per mg of delivered elemental iron.
- Normalization of Hb [ Time Frame: 4 weeks and 12 weeks ]Differences between the two groups of treatment in normalization of Hb; this is defined as Hb≥13 g/dl for mean and ≥12 g/dl for women.
- Ferritin levels [ Time Frame: 4 weeks and 12 weeks ]Differences between the two groups of treatment in ferritin levels.
- Absolute reticulocyte count [ Time Frame: 1 week, 4 weeks and 12 weeks ]Differences between the two groups of treatment in absolute reticulocyte count.
- Absolute RBC count, Hb, MCV and MCH [ Time Frame: 4 weeks and 12 weeks ]Differences between the two groups of treatment in absolute RBC count, Hb, MCV and MCH.
- Fatigue symptoms of IDA [ Time Frame: 4 weeks and 12 weeks ]Differences between the two groups of treatment in change of the fatigue symptoms of IDA.
- Physical findings of IDA [ Time Frame: 4 weeks and 12 weeks ]Differences between the two groups of treatment in change of physical findings of IDA.
- Incidence of GI side effects [ Time Frame: 4 weeks and 12 weeks ]Differences between the two groups of treatment in the incidence of GI side effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524651
|Contact: Evangelos Giamarellos-Bourboulis, MD, PhD||0030 210 firstname.lastname@example.org|
|General Hospital of Chalkida||Not yet recruiting|
|Chalkida, Greece, 34100|
|Contact: Nikolaos Tsokos, MD 30 22213 50459 email@example.com|
|Principal Investigator: Nikolaos Tsokos, MD|
|Sub-Investigator: Georgios Haliotis, MD|
|Attikon University Hospital||Recruiting|
|Haidari/Athens, Greece, 12462|
|Contact: Evangelos Giamarellos-Bourboulis, MD, PhD 0030 210 5831994 firstname.lastname@example.org|
|Principal Investigator: Evangelos Giamarellos-Bourboulis, MD, PhD|
|Sub-Investigator: Maria Argiropoulou, MD|
|Sub-Investigator: Evdoxia Kiriazopoulou, MD|
|Principal Investigator:||Evangelos Giamarellos-Bourboulis, MD, PhD||Attikon University Hospital|
|Principal Investigator:||Nikolaos Tsokos, MD||General Hospital of Halkida|