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Iron Deficiency clinical trials

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NCT ID: NCT06270498 Not yet recruiting - Clinical trials for Chronic Heart Failure

Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure

RISE-HF
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05950841 Not yet recruiting - Iron-deficiency Clinical Trials

Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman

Start date: January 1, 2024
Phase: Phase 3
Study type: Interventional

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but otherwise healthy premenopausal women over 12 weeks.

NCT ID: NCT05702970 Not yet recruiting - Heart Failure Clinical Trials

Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency

VICTORID-HF
Start date: January 15, 2024
Phase: Phase 4
Study type: Interventional

The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF. The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters. Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures. The study will involve randomization into 3 groups with a 1:1:1 ratio: 1. Control group [standard of care]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID. 2. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks. 3. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks

NCT ID: NCT05514951 Not yet recruiting - Iron-deficiency Clinical Trials

Study of the Prevalence of Iron Deficiency in Elderly Patient in Hospital Environment

CARENFERPA
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Iron deficiency is defined by insufficient tissue iron stores and anemia is the ultimate stage of iron deficiency. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology. In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient.

NCT ID: NCT05489094 Not yet recruiting - Iron-deficiency Clinical Trials

The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children

Start date: August 31, 2022
Phase: Phase 4
Study type: Interventional

The study will be conducted by the Indonesia Nutrition Association that led by a Principle Investigator and supported by the study team consisted of Nutritionists. The aims of the study are to reduce iron deficiency by increasing iron intake in children 1-3 years by providing interventions in the form of increasing iron intake from growing up milk for four months and nutrition education for the intervention group and nutrition education only for the control group.

NCT ID: NCT05407987 Not yet recruiting - Anemia Clinical Trials

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Start date: September 1, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05395468 Not yet recruiting - Iron-deficiency Clinical Trials

Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.

CaFerIA
Start date: September 2022
Phase:
Study type: Observational

The objective of our work is to predict the value of ferritin from the eye, thus constituting an original, non-invasive diagnostic method of iron deficiency. To be usable in real life, the algorithm must be comparable to the performance of the reference diagnostic test (determination of ferritin), allowing to obtain a sensitivity of about 90% and a specificity > 95%.

NCT ID: NCT05221957 Not yet recruiting - Colorectal Cancer Clinical Trials

Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery. The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside. The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included

NCT ID: NCT05220800 Not yet recruiting - Colorectal Cancer Clinical Trials

Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer

NAIDIC
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT04786769 Not yet recruiting - Aortic Stenosis Clinical Trials

Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

INERTIA
Start date: January 2022
Phase: Phase 4
Study type: Interventional

The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR. The primary endpoint is the time to HF hospital admission or cardiovascular death. Secondary endpoints will assess quality of life indicators and functional capacity at 6 months.