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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT02210949 Terminated - Clinical trials for Anemia, Iron-Deficiency

Pre-operative Treatment With Erythropoietin and Iron Supplement in Cardiac Surgery

Start date: August 2014
Phase: Phase 4
Study type: Interventional

Pre-treatment of patients with erythropoietin subcutaneously and iron supplement intravenously, in order to create a clinical pathway to minimize transfusion of red blood cells in a selected group of cardiac patients with an increased risk for blood transfusions in our cardiac surgery program.

NCT ID: NCT02177851 Completed - Anemia Clinical Trials

The Optimization of Bioavailability From Iron Supplements: Study 2

Start date: June 2015
Phase: N/A
Study type: Interventional

Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).

NCT ID: NCT02176759 Completed - Anemia Clinical Trials

Iron Absorption From Rice Fortified With Ferric Pyrophosphate

Start date: September 2014
Phase: N/A
Study type: Interventional

Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP need to be investigated. The primary objectives of the present study are: 1) to test whether the presence of citrate in iron fortified rice with FePP results in higher iron bioavailability, and 2) to test whether the presence of citrate in the rice grain during the extrusion and cooking process results in higher iron bioavailability compared with iron-fortified rice where citrate has been added shortly before consumption. As a secondary objective the investigators will compare the absorption from different FePP combinations with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the addition of citrate enhances iron absorption and that the positive effect is greater when the citrate is added during the extrusion. The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2) regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at the time of consumption. Iron absorption will be measured as erythrocyte incorporation of stable iron isotopes at least 14 days after the administration of the isotopically labelled test meals. The iron absorption from the different meals within the same participant will be compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison. The present study will provide important data where iron bioavailability from rice is accurately and directly measured using stable isotopic labels as absorption tracers. This direct data can be used to base decisions on the level of fortification, can potentially reduce costs and optimize iron delivery to the targeted population in iron fortification programs.

NCT ID: NCT02175888 Completed - Anemia Clinical Trials

The Optimization of Bioavailability From Iron Supplements: Study 1

Start date: October 2015
Phase: N/A
Study type: Interventional

Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily. The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.

NCT ID: NCT02172001 Withdrawn - Clinical trials for Iron Deficiency Anemia

A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

Start date: n/a
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.

NCT ID: NCT02170311 Completed - Clinical trials for Iron Deficiency Anemia

Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia

Start date: June 2014
Phase: Phase 1
Study type: Interventional

The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).

NCT ID: NCT02155114 Completed - Inflammation Clinical Trials

Iron Homoeostasis in Inflammation

Start date: April 2014
Phase: N/A
Study type: Observational

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

NCT ID: NCT02152150 Completed - Clinical trials for Iron Deficiency and Anemia

Feeding Trial of Bio-fortified Pearl Millet

Start date: September 2011
Phase: N/A
Study type: Interventional

The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet in improving iron status in adolescents in India.

NCT ID: NCT02130063 Completed - Clinical trials for Iron Deficiency Anaemia

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

Provide
Start date: May 2014
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

NCT ID: NCT02129907 Completed - Clinical trials for Iron Deficiency Anemias

The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.

Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured