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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT06238895 Recruiting - Clinical trials for Iron Deficiency Anemia

Optimizing Dosing Strategies in Oral Iron Supplementation

OPTIDOSE
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency anemia. The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose. Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).

NCT ID: NCT06219395 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Capsule Endoscopy in Iron Deficiency Anaemia

WCE-IDA
Start date: March 1, 2024
Phase:
Study type: Observational

This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)

NCT ID: NCT06200870 Not yet recruiting - Iron Deficiencies Clinical Trials

ID as a Promoter of IH-induced CAVD

Start date: January 1, 2024
Phase:
Study type: Observational

Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms. Elucidating viable therapeutic strategies for CAVD is pressing. Valvular interstitial cells (VICs) control the structure and function of aortic valve. Intra-leaflet haemorrhage (IH), commonly occurring in histologically stenotic aortic valves, while, in 2019, researchers pointed that iron deposits also presented obviously healthy valves. In line with this, later exploration from vitro showed that iron stimulation alone could not promote VICs calcification. Iron deficiency (ID) is a frequent co-morbidity in multiple chronic cardiovascular diseases such as CAVD; up to 50% of patients with severe aortic stenosis present ID. Data from a small clinical study in patients undergoing TAVI showed those in ID status appeared much higher mean transaortic gradient; whereas no studies have assessed the correlation between ID and aortic valve remodelling and dysfunction progress itself. Here, the investigators aim to investigate for a tentative correlation between ID and human aortic valve remodeling and dysfunction.

NCT ID: NCT06176430 Not yet recruiting - Cerebral Palsy Clinical Trials

Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

a randomized clinical trial to compare the effect of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy, to be conducted at Department of pediatric medicine children's hospital PIMS islamabad.

NCT ID: NCT06148545 Completed - Clinical trials for Iron Deficiency, Anaemia in Children

Effect of Iron and Vitamin D Supplementation to Iron Status in Iron Deficiency Anemia

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

Iron and vitamin D are two essential micronutrients for the normal growth of young children, and their deficiencies are still a major health problem in developing countries, including Indonesia. A significant association between vitamin D deficiency and anemia has been reported throughout the world. Several studies in various populations all over the world suggest a high degree of association between Iron deficiency anemia and vitamin D deficiency. It is still controversial which deficiency causes the other but this association should be addressed in view of a better treatment proposal. The aim of the present study was to determine the effect of vitamin D supplementation on iron status in iron deficiency anemia.

NCT ID: NCT06146608 Recruiting - Iron Overload Clinical Trials

Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption

FeMicrobiome
Start date: January 15, 2023
Phase:
Study type: Observational

The FeMicrobiome study will evaluate gut microbiome features and their relationships with dietary iron absorption in healthy adults. The investigators hypothesize that (1) the gut microbiota can be shaped by the heme and non-heme Fe content of the diet and that (2) this will influence individual variation in dietary Fe absorption.

NCT ID: NCT06116669 Recruiting - Clinical trials for Iron Deficiency Anemia

Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women

DIVA_II
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation. The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination). We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson & Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.

NCT ID: NCT06104800 Not yet recruiting - Obesity Clinical Trials

Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects With Obesity.

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Obesity and iron deficiency are the nutritional disorders with the highest prevalence worldwide. Different mechanisms have been proposed to explain iron deficiency secondary to obesity. Among the most studied is the deficit in dietary iron intake or the increase in blood volume that increases the need for the metal. However, one of the most plausible mechanisms linking obesity and iron deficiency is low-grade systemic inflammation, through the iron metabolism intermediate known as hepcidin. The investigators objective is to evaluate the effect of weight loss by caloric restriction on hepcidin and serum iron concentration in people living with obesity and iron deficiency. The study will be divided into two phases: Phase 1: A cross-sectional study (cases and controls) to compare hepcidin levels, iron status and inflammatory markers in people living with and without obesity. The second phase consists of an open-label randomized controlled clinical trial. Individuals living with obesity who are iron deficient will be recruited and randomized to one of 2 dietary intervention groups with 60-day follow-up. The intervention groups will be: diet with caloric restriction rich in protein (with red meat) and diet with caloric restriction rich in protein (without red meat). Hepcidin levels, iron status and inflammatory markers will be determined at the beginning and end of the intervention. The nutritional intervention will have the following distribution of macronutrients in the diet: protein 1.5 g/kg of ideal weight, 50% carbohydrates and 25-30% fats.

NCT ID: NCT06096103 Not yet recruiting - Clinical trials for Anemia, Iron Deficiency

A Clinical Study to Check the Safety and Effectiveness of Botanical Extract Standardized for Iron + Vitamin c and Botanical Extract Standardized for Iron in Adult Human Subjects With Anemia or Iron-deficiency Anemia

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

A randomized, double-blind, parallel, three-arms, placebo-controlled, safety and efficacy study of Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardized for Iron in adult human subjects with anemia or iron-deficiency anemia. A total of up to 96 adult male and female subjects of age 26 to 55 years (32 subjects/arm) will be enrolled to get 90 evaluable subjects (30 subjects/arm) in the study

NCT ID: NCT06084871 Recruiting - Clinical trials for Coronary Artery Disease

Patient Blood Management in Cardiac Surgery in Turkiye

PaBMiCS
Start date: June 1, 2023
Phase:
Study type: Observational

- Rationale and background: Surgical patients' transfusions have changed from replacing surgically lost blood with allogenic blood transfusions to implementing strategies that reduce transfusion requirements. Patient Blood Management (PBM) is designed to maintain hemoglobin concentration, optimize hemostasis, and minimize blood loss to improve patient outcomes. There is mounting evidence that multimodal PBM programs can improve postoperative outcomes and reduce perioperative blood transfusions and costs. The TULIP study in Turkey showed higher uses of blood transfusions in major surgical patients, including coronary artery surgeries in Turkey. The current studies also support the preoperative use of intravenous iron and/or vitamin B12/folic acid in major surgical patients. So, we aim to evaluate the efficacy of implantation of PBM in CABG surgeries in Turkey. - Research question and objectives: Is it possible to decrease the amount of perioperative blood and blood products transfusions by implementing PBM in patients who underwent CABG surgeries? The primary objective of the study is to demonstrate the reduction in perioperative RBC units transfused, when PBM is implemented in cardiac surgery in Turkey. The secondary objectives are to evaluate the concurrent reduction of FFP, platelet and total blood products used as compared to a control group, length of hospital and ICU stay following the surgery. - Study design: A prospective, multicenter, non-interventional study with a historical/retrospective control group. - Population: Patients who are operated on for coronary artery bypass grafting. - Variables: Demographic (age, sex), clinical (body mass index, comorbidities, ASA score, P-POSSUM score, Charlson Comorbidity Index), operative (type and duration of operations), laboratory (hemoglobin, platelet count, coagulation profile), laboratory for anemia (transferrin saturation, ferritin, creatinine clearance), preoperative treatment, transfusion data, and outcome (morbidity, mortality, lengths of hospital stay). - Exposures: Preoperative IV iron treatment of anemia. - Data sources: Medical data of the patients are obtained after entering a prespecified database (e-CRF) for the study subjects. For the control group, the medical data of the patients will be obtained retrospectively from the database of the TULIP study. - Study size: Study group: A total of 368 patients from five different centers across Turkey. Control group: at least 368 patients from the same centers attending the TULIP study. Finally, 736 patients will be included for the study.