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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT01950247 Active, not recruiting - Clinical trials for Iron Deficiency Anemia (IDA)

Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting

Start date: August 15, 2013
Phase: Phase 4
Study type: Interventional

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

NCT ID: NCT01942460 Completed - Inflammation Clinical Trials

Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients

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

The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol dose on various markers for iron stores, as well as on various markers for inflammation and oxidative stress.

NCT ID: NCT01925703 Completed - Heart Failure Clinical Trials

Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure

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

Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.

NCT ID: NCT01922479 Completed - Heart Failure Clinical Trials

Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure

PRACTICEASIAHF
Start date: September 2013
Phase: Phase 4
Study type: Interventional

Heart failure (HF) is a major global public health issue which also affects Asia. Data from the National Registry of Disease in Singapore shows a 9.4% rise in HF admissions in public hospitals from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common problem occurring in HF, ranging from 14% to 56% in outpatient registries and clinical trials. Anaemia exacerbates the basic symptoms of HF of dyspnea and exercise intolerance, thereby reducing quality of life (QoL). However, recent approaches aimed at improving and normalizing Haemoglobin have been unsuccessful.Novel approaches are required to address this problem. Iron deficiency (ID) is a well-understood cause of anaemia. ID without overt anaemia may be present in HF patients. A recent study by Jankowska et al published in 2010 of 546 HF patients showed a 37% prevalence of ID, regardless of Haemoglobin level. This was associated with worse outcomes including impaired exercise capacity. The presence of ID indicates a higher likelihood of deteriorating and dying early. A landmark study published in the New England Journal of Medicine (The Ferinject Assessment in Patients with Iron Deficiency and Chronic Heart Failure (FAIR-HF) study) showed that HF patients who were treated with IV iron in the form of Ferric Carboxymaltose (FCM) had better outcomes, including improved exercise capacity, overall function, and quality of life. There is a lack of contemporary data on ID in HF patients in Asia, including data on treatment with this novel IV iron FCM. Hypothesis We hypothesise that treating ID in HF patients in Asia using FCM will improve outcomes including exercise capacity, quality of life, overall functional status, and the need to be hospitalised for complications arising from HF.

NCT ID: NCT01908543 Terminated - Clinical trials for Hereditary Haemorrhagic Telangiectasia

Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

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

Managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid blood transfusions, or excessive strain on vital organs that depend on iron-containing haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and they often need additional iron to replace that lost through bleeding. Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra iron they need to adjust for their current and likely future blood losses; and to work out how to achieve this most safely for each individual to improve their later health. We will test the hypothesis that informed assessment of iron intake and post absorption cellular profiles changes the recommendations for iron intake for HHT patients.

NCT ID: NCT01904864 Completed - Clinical trials for Iron Deficiency Anemia

Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia

BESTIRON
Start date: July 2013
Phase: Phase 4
Study type: Interventional

This study is a randomized, controlled, double-blinded single center trial to compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency anemia (IDA) in infants and young children. Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin concentration during a twelve week course of treatment to subjects with iron deficiency anemia. Primary Aim: To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional IDA in infants and young children as determined by increase in hemoglobin concentration. Secondary Aims: 1. To compare the adverse effects of treatment for IDA between ferrous sulfate and NovaFerrum® 2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous sulfate or NovaFerrum® 3. To compare the adherence to study medication between subjects on ferrous sulfate and NovaFerrum® 4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional IDA

NCT ID: NCT01900197 Completed - Clinical trials for Iron Deficiency Anemia

Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)

Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.

NCT ID: NCT01895231 Completed - Iron-deficiency Clinical Trials

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

NCT ID: NCT01888003 Terminated - Clinical trials for Anemia, Iron-Deficiency

The Benefits of a Preoperative Anemia Management Program

PAMP
Start date: April 2013
Phase: N/A
Study type: Interventional

The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective surgery, with a series of weekly subcutaneous doses of a drug given before surgery, which stimulates the natural production of red blood cells (a so-called erythropoietic stimulating agent [ESA]) along with intravenous iron, in reducing the need for blood transfusions (donated by someone other than the patient) during and after adult total hip arthroplasty (hip replacement surgery). The effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery will also be examined. A cost-effectiveness analysis will be performed to compare the cost of these commercially available, FDA-approved medications versus the cost of transfused blood

NCT ID: NCT01878734 Completed - Stunting Clinical Trials

Zambia Micronutrient Powder Trial Effectiveness Study

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

Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the government due to its major contribution to morbidity and mortality among children, especially infants in their formative years. One of the most successful, cost-effective, and recommended strategy to address micronutrient malnutrition is 'in-home fortification' with micronutrient powders (Sprinkles being the most widely recognized) along with nutrition education. While this intervention has proven to be safe, effective, and efficacious in numerous other countries, a specific national protocol must be developed to maximize its effect on reducing anaemia in Zambian children. The proposed research aims to inform such protocol.