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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT05251493 Recruiting - Clinical trials for Iron Deficiency Anaemia in Childbirth

Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Start date: June 6, 2022
Phase: Phase 3
Study type: Interventional

Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion. The goal of this clinical trial: - Correct IDA with fewer visits and less impact on the healthcare system - Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.

NCT ID: NCT05225545 Recruiting - Ulcerative Colitis Clinical Trials

Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis

Start date: November 4, 2019
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.

NCT ID: NCT05217836 Recruiting - Sepsis Clinical Trials

Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

Start date: September 24, 2021
Phase:
Study type: Observational

Anemia is a common health problem. Depending on a geographical region, anemia affects even 50% of population. Among patients admitted to the intensive care unit (ICU) anemia may affect as much as 66% of patients. Moreover, many patients develop anemia during the ICU stay. In general population the most common cause of anemia is iron deficiency (ID). The investigators lack information on the incidence of ID and anemia of inflammation (AI) with absolute ID (mixed type of anemia: AI + IDA) or functional ID (AI) in patients with sepsis or septic shock hospitalised in the ICU. Therefore, the aim of the study is to improve diagnosis of iron deficiency (ID) and anemia of inflammation (AI) with absolute ID (AI + IDA) or functional ID (AI) in patients with sepsis or septic shock. ID have negative effects on the body and is associated with impaired production of proteins responsible for transport of oxygen in the blood (hemoglobin) and oxygen storage (myoglobin), and impaired immune function. Development of anemia is associated with well documented complications: organ hypoxia, myocardial infarction, stroke, infection. Replenishment of iron at this early stage may potentially prevent IDA. It is advantageous to replenish iron stores in order to avoid these complications, especially in patients with sepsis or septic shock. In IDA red blood cell transfusion is not recommended as it leads to other numerous complications. Therefore the patients presenting with laboratory results suggesting ID will receive divided doses od parenteral iron. Monitoring of iron replenishment will be based on a new laboratory parameter- reticulocyte hemoglobin equivalent.

NCT ID: NCT05187637 Recruiting - Clinical trials for Iron Deficiency Anemia

.Patient Blood Management Program in Liver Transplantation

PBM-THO
Start date: March 23, 2022
Phase:
Study type: Observational

Transfusion management improvement programs, generally known as patient blood management (PBM) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components. In a recent series of liver transplants (LT) performed in Spanish centers belonging to the Spanish Liver Transplant Society, despite optimal hemostasis management and preservation of the vena cava, around 20% of patients required massive transfusion (considered as the administration of 6 or more red blood cell concentrates intraoperatively). In addition, 63% of the patients were transfused with at least one packed red cells during the operation. By correcting the iron deficiency in patients who meet the criteria of the anemia study (transferrin saturation less than 20%), we could improve the hemoglobin level, which would allow a wider margin for the transfusion of red cell concentrates.

NCT ID: NCT05179226 Recruiting - Clinical trials for Iron Deficiency, Anaemia in Children

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia

Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

Several clinical trials have been reported for ferric derisomaltose where it has been shown to be well tolerated and to improve markers of IDA. All clinical trials with ferric derisomaltose have been performed in adults, however, IDA is not specific to the adult population. In fact, children are likely to develop IDA due to their rapid growth. The aim in this trial is to evaluate the efficacy and safety of intravenous (IV) ferric derisomaltose in children 0 to <18 years of age with IDA due to NDD-CKD or with IDA who are intolerant or unresponsive to oral iron . The subjects will receive ferric derisomaltose/iron isomaltoside 1000 (Monoferric®/Monofer®), at single doses of 10 mg/kg or 20 mg/kg with a maximal dose of 1000 mg. 24 subjects will be part of a PK assessment, meaning that more blood samples will be drawn within the first week after treatment. The blood samples will be used for analysis of the amount of total iron in the blood from treatment is given to day 7. For the individual subject, duration of the trial will be approximately 10 weeks (including a 14-day screening period) and each subject will attend 6-9 visits. Subjects who will be included in the PK assessments will attend 8 (subjects age 6 to <12 years old and 0 to <6 years old) or 9 (subjects age 12 to <18 years old) visits, while the other subjects will attend 6 visits.

NCT ID: NCT05165680 Recruiting - Obesity Clinical Trials

Effect of Aerobic Exercise and Diet on Anthropometric and Hematological Measurements in Obese Anemic Women

Start date: July 3, 2021
Phase: N/A
Study type: Interventional

Obesity and iron deficiency (ID) are two forms of the most usual nutritional disorders worldwide. Iron deficiency remains the most common nutritional deficiency and cause of anemia worldwide. Populations in the developing countries, premenopausal females, pregnant women, children, vegetarians and frequent blood donors are largely affected by iron deficiency due to low dietary intake, inadequate bioavailable iron, increased iron demand required for growth and development, iron losses and changes in blood volume. WHO recognized obesity as disease, which is prevalent in both developing and developed countries. Overweight and obesity are now so common and thereby replacing the more traditional public health concerns (under nutrition and infectious diseases) as some of most significant contributors to ill health. The aim of this study is to investigate effect of aerobic exercise and diet on obese anemic premenopausal women which not clarified previously. It will be hypothesized that: There will be no significant effect of aerobic exercise and diet on the anthropometric and hematological measurements in obese anemic women.

NCT ID: NCT05126901 Recruiting - Anemia Clinical Trials

Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years

FORTIS
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The objective of the study is to compare the safety and gastrointestinal tolerability of ferric maltol oral suspension and ferrous sulfate oral liquid in children and adolescents aged 2 years to 17 years, and assess the safety and tolerability of ferric maltol oral suspension in children 1 month to less than 2 years, in the treatment of iron deficiency anaemia during the 12 weeks treatment period.

NCT ID: NCT05103709 Recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Multiple Micronutrient Fortified Bread Consumption on Iron Deficiency Anemia in Women of Reproductive Age

Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The project aims to assess if consuming two slices of multi-fortified bread daily for 120 days is effective in reducing iron deficiency anemia in women of reproductive age through a three-arm randomized trial.

NCT ID: NCT04945707 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

IRONMETHFpEF
Start date: November 26, 2021
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine if the correction of functional iron deficiency by administering a single dose of intravenous iron (ferric derimaltose or Monoferric®) in participants with heart failure with preserved ejection fraction (HFpEF) will improve exercise capacity as measured by the change in peak oxygen uptake (peak VO2) from baseline to 12 weeks.

NCT ID: NCT04931641 Recruiting - HIV Clinical Trials

Potential of Prebiotic Galacto-oligosaccharides in Improving Efficacy and Safety of Oral Iron Supplementation in HIV-infected Children

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The objectives of this randomized controlled trial in virally suppressed HIV-positive children with anemia and/or depleted iron stores are to determine the effect of prebiotic galacto-oligosaccharides (GOS) as adjunct treatment to 12 weeks of oral iron supplementation on: 1. iron status measured by conventional iron status biomarkers, 2. fractional absorption of iron (fraction of total body iron per day, measured as Kabs, the slope of 57Fe isotopic dilution) and mean total amount of iron absorbed each day (mg Fe/day, calculated as Kabs x mean total body iron), 3. systemic and gut inflammation, as well as gut mucosal integrity, 4. gut microbiome composition, and 5. adverse effects and gastrointestinal side-effects.