Iron Deficiency Anemia

This NIH-sponsored study aims to characterize three biomarkers derived from 129Xe gas exchange MRI and understand how they change in response to interventions. The study focuses on markers derived from the interaction of 129Xe with pulmonary capillary red blood cells RBCs, specifically RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift. The study population includes healthy volunteers, patients scheduled to undergo transfusion or phlebotomy, patients with dyspnea, interstitial lung disease ILD, idiopathic pulmonary fibrosis IPF, non-specific interstitial pneumonias NSIP, chronic hypersensitivity pneumonitis cHP, sarcoid, chronic thromboembolic pulmonary hypertension CTEPH, and acute pulmonary embolism.

Researchers are evaluating a new combination of evidence-based interventions EBIs aimed at improving diagnostic safety and efficiency in primary care for patients with anemia and decreased glomerular filtration rate. The study is designed as a stepped wedge cluster randomized control trial to measure how these interventions affect patient safety and healthcare efficiency, while also assessing factors influencing their implementation such as acceptability, cost, and sustainability. The study compares an enhanced diagnostic team approach to usual care. The enhanced approach includes automated detection and tracking of abnormal test results, expanding the primary care team to include clinical pharmacists to guide anemia evaluation, and engaging patients through nurse navigators to increase their activation in the diagnostic process. The study involves several clinic groups that receive the intervention at different times, ranging from 12 to 24 months, with some initial control periods. Participants will have their diagnostic accuracy for causes of low hemoglobin and decreased glomerular filtration rate assessed within six months. Researchers will track time to diagnosis, appropriate test usage, treatment costs, and primary care physicians views on the interventions acceptability and feasibility. The study also monitors how well the diagnostic process steps are followed, the interventions reach among patients, and sustainability in clinics over 2.5 years. Patient activation and clinic-level facilitators and barriers are evaluated through surveys and measures during the study period.

This research aims to evaluate how human lactoferrin combined with low-dose iron affects iron levels, aerobic fitness, and lactate metabolism in women who exercise and have low iron stores. The study focuses on healthy menstruating women aged 18 to 45 years with serum ferritin below 35 gL, aiming to understand if lactoferrin can improve iron regulation and exercise outcomes. Iron deficiency is common in active women and can reduce oxygen delivery and exercise performance, making this study important for finding better supplementation methods. Participants will be randomly assigned to one of three groups for an 8-week period receiving 100 mg lactoferrin plus 5 mg iron daily, 300 mg lactoferrin plus 5 mg iron daily, or a placebo plus 5 mg iron daily. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment. The intervention is oral supplementation taken daily, and participants will attend six visits including screening, baseline, and follow-ups at weeks 2, 4, 6, and 8. During the study, participants will undergo blood tests to measure iron biomarkers and blood parameters, along with assessments of aerobic capacity using treadmill tests measuring VO2peak, time to exhaustion, and blood lactate levels. Questionnaires will evaluate gastrointestinal symptoms, menstrual symptoms, quality of life, and recovery perception. Daily supplement adherence and any side effects will be monitored throughout. The primary outcome is the change in serum ferritin concentration over time, while secondary measures include changes in hemoglobin, hematocrit, red blood cell count, and exercise performance indicators.

Researchers are evaluating the effects of a dietary supplement on blood-based nutritional biomarkers in healthy children aged 4 to 15 years. This pilot clinical study aims to gather preliminary data on how the supplement influences serum levels of vitamin D, vitamin B12, folate, omega-3 fatty acids, and other blood count parameters. The study is conducted by SF Research Institute, Inc. and focuses on understanding nutritional status through biomarker changes. The study involves a single group of participants who will take an investigational gummy dietary supplement called Kids Multi & Omegas. Children will be instructed to take two gummies once daily, with or without food, for a total of 4 weeks. Blood samples will be collected at the start and end of the study to assess changes in selected serum nutritional biomarkers. Participants will also undergo measurements of height, weight, and body mass index, and complete a socioeconomic questionnaire. Participants will attend two clinic visits one for screening and baseline assessments and another at the end of the 4-week supplementation period. During the study, children or their caregivers will keep a daily diary recording supplement intake, medication use, and any side effects. Researchers will review compliance, collect blood samples, and assess changes in nutritional biomarkers and physical measurements. The total study duration for each participant is approximately 4 weeks.

Researchers are evaluating luspatercept to see if it can improve hemoglobin levels in adults with anemia caused by chronic kidney disease CKD. This study also aims to assess the safety of luspatercept by monitoring side effects in participants. The trial is a phase 2 treatment study sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive luspatercept as a subcutaneous injection once every three weeks. The study does not include a comparison group and focuses on how luspatercept affects hemoglobin levels over time, particularly within 12 weeks and up to week 28. The treatment period is designed to test the effects and safety of the drug in this patient group. During the study, participants will have their hemoglobin levels closely monitored to measure improvements. Researchers will also evaluate other health indicators to ensure safety and effectiveness. The study involves regular visits for treatment and assessment, with the overall participation lasting up to the study completion date in July 2029.

Researchers are investigating whether the amount of iron in tears is connected to the severity of dry eye disease. This observational study compares tear samples from people with dry eye to those from individuals with healthy eyes. The goal is to find new ways to diagnose and understand dry eye by analyzing tear iron levels alongside standard dry eye test results and symptom scores. Participants will have a single study visit involving tear fluid collection using sterile Schirmer test strips without anesthesia, placed in the lower conjunctival sac for 5 minutes. They will also undergo a detailed eye surface evaluation, including the Ocular Surface Disease Index questionnaire and clinical tests such as fluorescein tear film breakup time, corneal fluorescein staining scoring, and Schirmer I test. The tear samples will be analyzed for iron concentration. During the study visit, researchers will assess symptoms and conduct clinical tests to measure tear film stability, tear secretion volume, and corneal epithelial damage. The main measure is the correlation between tear iron levels and dry eye symptom severity. This single diagnostic visit includes no treatment, and participants usual eye care remains unchanged. The study is expected to continue until May 2029.

Researchers are evaluating how well elritercept works to improve anemia in adults with myelofibrosis MF who are already taking ruxolitinib. The study compares elritercept to a placebo and aims to see if elritercept can reduce tiredness, improve MF-related symptoms, and help participants perform physical activities more easily. It also looks at elritercepts effects on bone marrow, spleen size, antibody development, and long-term safety. Participants receive either elritercept or a placebo by subcutaneous injection once every 4 weeks during a 36-week double-blinded treatment period. The starting dose of elritercept is 3.75 mgkg, with a possible increase to 5.0 mgkg after the second cycle based on response and safety. After 36 weeks, participants who took placebo may switch to receive elritercept in an extended open-label phase. During the study, participants undergo assessments including blood transfusion independence, symptom and fatigue questionnaires, spleen imaging, and bone marrow evaluation. Researchers monitor safety, antibody formation, and survival for up to 7 years. The main outcome is the proportion of participants who become independent from red blood cell transfusions for at least 12 consecutive weeks during the 36-week treatment. Participants are involved in regular visits and evaluations throughout the treatment and follow-up periods.

Researchers are evaluating elritercept for its ability to reduce the need for red blood cell RBC transfusions and its safety compared to epoetin alfa in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who require regular blood transfusions. The study aims to understand if elritercept improves tiredness, lowers transfusion burden, enhances quality of life, and elicits an immune response. Participants receive either elritercept or epoetin alfa injections. Elritercept is given as a subcutaneous injection starting at 3.75 mgkg every 4 weeks, with possible dose increases to 5.0 mgkg. Epoetin alfa is administered as a subcutaneous injection starting at 450 IUkg once weekly, with possible dose escalation up to 1050 IUkg. The study follows participants for approximately 5 years to monitor treatment effects and safety. During the trial, participants are regularly assessed for transfusion independence, hemoglobin levels, fatigue, quality of life, and hematological improvements. Researchers monitor blood samples for drug concentration and immune response. Safety is evaluated through medical history, lab tests, and adverse event tracking. The main outcome is the proportion of participants achieving RBC transfusion independence for at least 12 weeks during the first 24 weeks. The study uses questionnaires and clinical assessments to measure fatigue and quality of life.

Researchers are evaluating the efficacy and safety of luspatercept combined with best supportive care compared to placebo with best supportive care in adults with alpha-thalassemia hemoglobin H disease who experience anemia. The study also assesses the safety and drug levels of luspatercept in adolescents with this condition. This phase 2 trial aims to understand how luspatercept affects anemia and transfusion needs in this population. Participants are randomly assigned to one of four groups based on their transfusion dependence status adults who receive luspatercept plus best supportive care, adults who receive placebo plus best supportive care, adolescents who are transfusion dependent receiving luspatercept plus best supportive care, or adolescents who are non-transfusion dependent receiving luspatercept plus best supportive care. The treatments are given on specified days, and participants are monitored for up to 108 weeks, including assessments of drug levels, transfusion burden, hemoglobin changes, and adverse events. Throughout the study, participants undergo regular evaluations including blood tests to measure hemoglobin and transfusion needs, monitoring for side effects, and quality of life assessments. Researchers also track long-term safety outcomes and pharmacokinetics of the drug. The main outcomes include reductions in red blood cell transfusions over 12 to 48 weeks and increases in hemoglobin levels without transfusions. Participants may be followed for up to five years to monitor safety and treatment effects.

This research aims to evaluate the safety, effectiveness, and how the body processes ferumoxytol for treating iron deficiency anemia IDA in children aged 2 to under 18 years. The study includes male and female pediatric subjects with IDA or those considered at risk of developing IDA by their clinician, regardless of cause, except for those with chronic kidney disease CKD, who are studied separately. Participants will be randomly assigned in a 21 ratio to receive either ferumoxytol or iron sucrose. Ferumoxytol is given as two intravenous doses of 7 mg iron per kg, with a maximum of 510 mg per dose the first dose is on Day 1 and the second dose is 2 to 8 days later. Iron sucrose is given as five intravenous doses of 4 mg iron per kg, with a maximum of 200 mg per dose the first dose is on Day 1 and the remaining doses are given at least once per week and up to three times per week. Participants are monitored for one hour after each infusion. Throughout the study, which lasts up to 5 weeks, researchers will assess hemoglobin levels, check for side effects or adverse events, and perform other safety tests. The main outcome measured is the change in hemoglobin from the start to Week 5. Additional safety assessments include tracking any new or special adverse events up to 49 days after treatment begins.