Iron Deficiency

The goal of this clinical trial is to evaluate whether an AI-based risk notification system integrated into routine clinical care can improve the clinical detection of iron deficiency in adult patients attending Internal Medicine, Family Medicine, and Hematology/Oncology clinics at China Medical University Hospital in Taiwan. The main questions this study aims to answer are: 1. Does displaying AI-generated iron deficiency risk classification to physicians increase the overall detection rate of iron deficiency at the population level? 2. Does the AI-based risk notification influence physicians' diagnostic behavior by increasing the rate at which ferritin testing is ordered specifically for suspected iron deficiency? 3. Among ferritin tests ordered for suspected iron deficiency, does the diagnostic yield (positivity rate) remain appropriate, reflecting efficient use of testing resources? 4. Are the effects of the AI-assisted intervention consistent among patients with anemia and without anemia? Comparison Groups Researchers will compare clinical encounters in which physicians receive AI-generated iron deficiency risk information (the Prompt Group) with encounters in which physicians receive standard laboratory results without AI risk display (the Control Group). The comparison focuses on differences in iron deficiency detection, ferritin ordering behavior for suspected iron deficiency, and diagnostic yield. What Participants Will Experience 1. No Additional Procedures: As this is a pragmatic study embedded in routine clinical care, participants will not undergo any additional blood draws, invasive procedures, or clinic visits beyond standard care. 2. Routine Care Only: Patients attend their scheduled outpatient visits and receive complete blood count (CBC) testing as ordered by their treating physician, independent of study participation. 3. Background Data Integration: The AI system operates within the hospital's information system, analyzing routinely collected CBC data after results become available. No additional data entry or action is required from patients. 4. Physician Autonomy Preserved: The AI provides a non-mandatory risk classification as decision support. For patients identified as high risk, the system may display an informational prompt suggesting consideration of iron-related testing if no recent testing is found. All diagnostic and management decisions remain entirely at the discretion of the treating physician.

In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants. Investigators hypothesize that in infants \< 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome

The aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1/R2/R2\* which are well established as accurate indicators of tissue iron content.

This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.

This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \<35 µg/L will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily. Primary outcomes include changes in ferritin and hematological parameters. Secondary outcomes include VO₂peak, time to exhaustion, and blood lactate responses during standardized treadmill testing. This study will determine whether lactoferrin enhances iron homeostasis and improves physiological and performance outcomes in exercising women with low iron stores.

The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are: * Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements? * Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms? * How do iron supplements affect exercise performance and gut bacteria? Researchers will compare three types of iron supplements: * A low-dose iron supplement (40 mg) * A low-dose yeast-bound iron supplement (40 mg) * A high-dose iron supplement (150 mg) This will help researchers find out which type of supplement is most effective and easiest on the stomach. Participants will: * Take one of the three assigned iron supplements every other day for 12 weeks * Complete fitness tests before and after the study, including cycling and jumping tests * Give blood samples to measure iron levels * Provide stool and intestinal samples to study gut bacteria * Swallow a SIMBA capsule before and after the study to collect a sample from the small intestine * Complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms

Young women living with obesity (OB) have a greater risk of developing iron deficiency. Plus, the risk of anemia and/or ID in young women living with overweight (OW) and obesity (OB) is further increased by inadequate dietary intake and/or poor bioavailability of iron, as well as gastrointestinal and menstrual iron losses. It is not certain whether women living with OW/OB can meet their iron requirements from their day-to-day diet. The aim of this study is to compare iron absorption and losses over a long period between women living with and without OW and OB. Secondary outcomes include iron and inflammation status, as well as dietary iron intake.

The aim of the study is to validate short questionnaires for assessing dietary intake of selected food components, with a focus on dietary fibre and iron. Two internationally developed short questionnaires (FiberScreen \[for dietary fibre\] and IRONQ-FFQ \[for iron\]) were adapted to the Slovenian context and will be compared with the standard 24-hour dietary recall method.

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.

Pulmonary hypertension (PH) is a condition characterized by elevated blood pressure in the pulmonary arteries. This leads to symptoms such as shortness of breath and a significantly reduced exercise capacity, resulting in a very poor quality of life. Currently, treatment options for PH are limited. More than 60% of patients with PH develop iron deficiency. Studies have shown that this deficiency is associated with more severe symptoms, reduced exercise capacity, and even lower quality of life. Oral iron supplements are often ineffective in these patients due to impaired absorption in the intestines, caused by chronic low-grade inflammation-a common feature in PH. Intravenous iron administration can rapidly correct the deficiency, but it remains unclear whether this also leads to clinical improvements such as enhanced exercise capacity, reduced shortness of breath, and improved quality of life. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions. As part of the IRON-PH study, 306 patients with pulmonary hypertension will be enrolled. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).

The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI). The main questions it aims to answer are: 1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? 2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? The intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)). Participants will: * Provide written informed consent * Be randomly assigned to one of two groups: 1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks) 2. Control group: receiving standard of care (= no iron therapy) * Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI. * During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)

The relationship between iron deficiency (with or without anemia) and arrhythmic risk or ECG abnormalities in hospitalized HF patients remains poorly characterized. This is particularly relevant in settings where advanced iron therapies (e.g., intravenous iron supplementation) may not be readily available, and where simple clinical and electrocardiographic markers could help identify high-risk patients by evaluating the impact of iron deficiency (with and without anemia) arrhythmic events and resting ECG changes among patients admitted with heart failure. Understanding these associations may offer insights into the arrhythmogenic potential of iron deficiency and support the integration of iron status assessment into routine risk stratification and management of HF patients.

Adolescents and young adults undergoing spinal fusion surgery for the correction of scoliosis and other spinal deformity are at high risk of perioperative iron deficiency and anemia, yet the means and evidence for optimizing iron status have not been described in this setting. The proposed study is a randomized controlled trial of preoperative intravenous iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in this vulnerable population. Building evidence for patient blood management interventions such as iron supplementation is vital to ensuring high quality care of surgical patients and may reduce unnecessary transfusions amid recent blood shortages.

The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID). The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo. One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.

The goal of this clinical trial is to learn whether oral iron supplementation will increase skeletal muscle iron storage and its effects on exercise capacity in females with suboptimal iron status. The study will include healthy females, ages 18-40, who either have suboptimal or optimal iron stores. The main questions it aims to answer are: * Does iron supplementation increase skeletal muscle iron storage and alter the expression of iron-related and mitochondrial proteins? * Does iron supplementation improve single-leg exercise performance? * Is serum ferritin correlated with the abundance of iron-related proteins in skeletal muscle? Researchers will compare outcomes from females with suboptimal iron status who receive oral iron supplementation to those who receive a placebo to see if supplementation improves muscle iron storage, protein expression, and exercise performance. Additionally, a non-intervention control group with optimal iron status will be included to assess baseline differences. Participants will: \- Be randomly assigned to receive 150 mg elemental iron or placebo (maltodextrin) every other day for 12 weeks Complete pre- and post-supplementation testing, including: * Blood draws to assess iron status * Skeletal muscle biopsies to analyze protein content * Whole-body and single-leg exercise tests to assess performance * Controls will undergo baseline-only testing to compare physiological and biochemical markers

The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a Finnish general population. Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome

Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy. In addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.

The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent. The main questions the study will answer are: 1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks? 2. Does IV iron improve symptoms and quality of life more than oral iron? 3. How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality? Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better. What participants will do * Be randomly assigned by (like flipping a coin) to IV iron or oral iron. * Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks. * Visit the infusion clinic at 6 weeks for second dose of IV iron if needed. * Visit the clinic at 12 weeks for a follow-up to gather follow-up data including 1. A 6-minute walk test 2. Brief symptom and quality-of-life surveys 3. Blood tests to measure serum iron, ferritin, and transferrin saturation This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.

Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates. This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia. The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.

This study aims to understand how to best manage iron deficiency in children newly diagnosed with celiac disease. Many children with celiac disease have low iron levels, even if they do not have anemia. While some doctors recommend iron supplements, others believe that simply following a gluten-free diet may be enough to restore iron levels naturally. In this study, children with newly diagnosed celiac disease and low iron levels (but normal hemoglobin) will be randomly assigned to one of two groups: Gluten-Free Diet Only - No additional iron supplements Gluten-Free Diet + Iron Supplementation Researchers will compare iron store levels over one year to see if iron supplements provide any additional benefit beyond the gluten-free diet alone. The study will also track possible side effects of iron supplements, such as stomach discomfort. This study will help doctors determine the best approach to managing iron deficiency in children with celiac disease, ensuring they receive the safest and most effective treatment.

The aim of this prospective observational cohort study is to study maternal iron deficiency and iron deficiency anemia and the use of iron supplements in pregnancy and their impact on the health of the offspring and pregnancy outcomes. All women coming to Tampere University Hospital for prenatal checkups and/or labor are recruited to the study. After giving their consent the mothers fill an online questionnaire about about possible maternal anemia and its diagnosis in pregnancy, iron deficiency and its diagnosis in pregnancy, maternal use of iron supplement or folic acid and it´s timing, about possible other chronic disease and their medications during pregnancy, and whether the mother has got intravenous iron infusions in pregnancy. Mothers also give their permit to use their in-and outpatient data from pregnancy until hospital discharge and to follow the health of their offspring from birth until 7 years of age from in- and outpatient records.We aim to recruit 6000 mother-child-pairs. The health of the offspring (growth, diagnoses, medication, possible therapies, need of support at daycare or school) will be followed for the first month, then at 1,5 years, four years and seven years of age from the patient records. In addition to the cohort study, two nested cohort studies will be performed. The aim of the nested cohort studies is to study the correlation of maternal iron status to the iron status of the child. Secondary aim is to evaluate iron biomarkers, especially reticulocyte hemoglobin, and their reliability to interpret neonatal iron status. A 100 mothers with diagnosed iron deficiency and iron supplementation (p.o. or i.v.) in pregnancy, are recruited to Nested cohort 1. For the nested cohort 2, a 100 mothers with diabetes requiring insulin therapy in pregnancy are recruited. Tor these two cohorts, a 100 mothers without iron deficiency or diabetes will be recruited as controls. Iron status of the mother will be tested before delivery from blood sample. The iron status of the offspring will be checked from umbilical blood, at 2 days of age at the same time other lab tests are taken, at eight months and two and five years of age. In addition to the laboratory tests, parents fill up an electronical questionnaire at eight months, two and five years about the nutrition, sleep, behaviour and cognitive and motor skills of their child. The researchers try to find out, whether iron deficiency in pregnancy has long-term effects on the health and development of the offspring, and how the iron status correlates between the mother and the child, and does it have impact on their sleep, behaviour or skills.

This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.

The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are: * What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? * How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? The investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and/or anemic women undergoing the menopausal transition. Each participant will: * Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue * Make a very brief visit at midpoint (about 10 minutes) for a checkup * Take a daily study supplement or placebo for 4 months

This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study. Study outline: After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel