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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT02031289 Completed - Anemia Clinical Trials

Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

Start date: December 2013
Phase: Phase 4
Study type: Interventional

We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. The study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice . - Trial with medical product

NCT ID: NCT02009943 Withdrawn - Clinical trials for Functional Iron Deficiency

Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill

Start date: February 2017
Phase: Phase 1
Study type: Interventional

Critically ill surgical patients are observed to have a functional iron deficiency which contributes to anemia, iron-deficient erythropoiesis, and an increased red blood cell transfusion requirement. Previously, iron supplementation has been studied in this population with the administration of enteral ferrous sulfate and intravenous iron sucrose but without robust results in resolving serum and bone marrow iron debts. Ferric carboxymaltose (FCM) is novel iron-containing complex that allows for the administration of a large dose of iron over a short infusion period to allow for sustained delivery of iron to target tissues with minimal hypersensitivity reactions. While there has been reported increased efficacy and comparable safety of FCM when compared to iron sucrose in the outpatient setting, there is no data comparing these two medications in surgical critical illness. The aim of this pilot trial is to compare two novel dosing schemes of these medications for treatment of functional iron deficiency in surgical ICU patients. The investigators hypothesize that iron supplementation with FCM, as compared to both iron sucrose and placebo, is more effective and equally safe for replacing the serum iron debt.

NCT ID: NCT02005588 Completed - Clinical trials for Iron Deficiency Anemia of Pregnancy

Treatment of Iron Deficiency Anemia With Pregnancy

Start date: December 2013
Phase: Phase 0
Study type: Interventional

Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the investigators are going to compare the efficacy and tolerability of two preparations of oral iron in treatment of iron deficiency anemia with pregnancy.

NCT ID: NCT01991626 Completed - Iron Deficiency Clinical Trials

Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods

Start date: September 2013
Phase: N/A
Study type: Interventional

Previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic phytic acid removal through phytase. The investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (LNS) products compared to micronutrient powder(MNP) products. Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.

NCT ID: NCT01991600 Completed - Clinical trials for Iron Deficiency Anaemia

A Pilot Study to Assess the Influence of Dietary Organic Acids on Iron Absorption.

Start date: May 2006
Phase: Phase 0
Study type: Interventional

Iron deficiency is the most common micronutrient deficiency in the world today, affecting more than 60% of the global population (www.who.int/nut/ida.htm). The two main strategies for the prevention and treatment of iron deficiency involve fortification of food with iron, or direct supplementation with iron tablets. Simple iron salts (e.g. ferrous sulphate) are well absorbed but at supplemental levels (and potentially at lower levels, as used in food fortificants) can induce free radical activity resulting in gastrointestinal side effects and systematic oxidative stress. As a result, supplementation has poor compliance and improvement in iron status is compromised. Ferric salts are less inclined to produce side effects and although they are relatively well absorbed at fortification levels in food, they are poorly absorbed at the higher supplemental doses. Because certain components of food, such as organic acids, can facilitate ferric iron absorption, we now wish to determine whether dietary organic acids may similarly enable efficient absorption of supplemental ferric iron while preventing the formation of non-transferrin-bound iron (NTBI) which is a proxy for free radical activity. Our strategy is to use an iterative process between in vitro and in vivo experimentation, aimed at identifying the best choice of organic acid and the optimal ratio of iron:organic acid. The study was a cross-over, single-dose comparison against standard-of-care therapy (namely ferrous sulphate) in mildly iron deficient anaemic women. Both the investigational products and the active comparator were administered as a single dose on 2 different occasions, i.e. the investigational products on the first study visit and the active comparator 14 days later on the second study visit.

NCT ID: NCT01991314 Completed - Ulcerative Colitis Clinical Trials

Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate

Start date: December 2011
Phase: Phase 4
Study type: Interventional

Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy. IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity. To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.

NCT ID: NCT01985386 Completed - Iron Deficiency Clinical Trials

Iron Absorption From GDS Capsules II

Start date: November 2013
Phase: N/A
Study type: Interventional

Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.

NCT ID: NCT01984554 Completed - Clinical trials for Iron Deficiency Anemia (IDA)

Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

Start date: September 2013
Phase: N/A
Study type: Observational

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

NCT ID: NCT01978535 Terminated - Clinical trials for Postural Orthostatic Tachycardia Syndrome

Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Start date: December 17, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to investigate whether the treatment of non-anemic iron deficiency with intervenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in adolescents (age 12-21) with Postural Orthostatic Tachycardia Syndrome (POTS).

NCT ID: NCT01978028 Terminated - Heart Failure Clinical Trials

Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose

Start date: October 2013
Phase: Phase 4
Study type: Interventional

The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.