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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT06287619 Not yet recruiting - Cardiac Surgery Clinical Trials

Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

POAM
Start date: April 2024
Phase: Phase 2
Study type: Interventional

POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo.

NCT ID: NCT06276140 Not yet recruiting - Colorectal Cancer Clinical Trials

Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery

ID-COLO
Start date: April 2024
Phase:
Study type: Observational

The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are: - whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery - whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients. Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin. Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected. The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices.

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: 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: 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: NCT06061393 Not yet recruiting - Clinical trials for Anemia, Iron Deficiency

Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia

Start date: October 30, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin <9 gr/dl , treated with venofer and women treated with ferinject.

NCT ID: NCT05957328 Not yet recruiting - Nutritional Anemia Clinical Trials

A Study to Compare Liposomal Iron With Ferrous Ascorbate in the Treatment of Iron Deficiency Anemia in Children

Start date: August 2023
Phase: Phase 3
Study type: Interventional

This trial is designed to compare the efficacy of ferrous ascorbate versus liposomal iron for the treatment of nutritional iron deficiency anemia (IDA) amongst 6 to 59 months age children as determined by the increase in hemoglobin concentration and change in iron indices after 12 weeks of treatment. This study will be a randomized double-blinded single-center study done at the outpatient department of the Department of Pediatrics. All the children between 6 months to 59 months with nutritional IDA will be enrolled in the study. Written informed consent will be taken from the caregiver. At baseline detailed history will be taken and a complete physical examination will be done. Complete blood count (CBC), Peripheral smear, corrected reticulocyte count, Serum iron, Serum ferritin, and serum Total iron binding capacity(TIBC) will be done at baseline. Transferrin saturation will be calculated with the formula Serum Iron/ TIBC ×100. C Reactive Protein (CRP) and alpha1- acid glycoprotein (AGP) will be done to look for inflammation. Eligible subjects would be randomized in a 1:1 ratio by computerized software to receive either ferrous ascorbate or liposomal iron. Subjects in the ferrous ascorbate group would be given the drug at a dose of 3mg/kg/day OD of elemental iron. Subjects in the liposomal group would be given 1mg/kg/day OD of liposomal iron. Follow-up visits would be done at 4 and 12 weeks. Follow-up at 4 weeks is required to check the initial response to treatment and identify nonresponders and at 12 weeks is required to see the final response and thus decide upon continuation or discontinuation of treatment. In the follow-up visit at 4 and 12 weeks, CBC, Iron profile (Iron, Ferritin, and TIBC), CRP, and AGP will be done. Corrected Reticulocyte will be done at 4 weeks only. Any adverse effects of therapy will be noted. Adherence to therapy will be checked by measuring the volume of unused medicine in the bottle at each visit. All the statistically analyzed continuous data will be presented as mean ± standard deviation (SD). The categorical data will be reported as a percentage. Student's t-tests will be used to compare means. The χ2 test will be used to compare categorical outcomes, including the proportion of patients with dropouts, adverse effects, and adherence measures. The percentage volume of unused study medication returned at each visit will be compared using the Wilcoxon rank sign test. p<0.05 will be considered statistically significant.