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Anemia clinical trials

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NCT ID: NCT05792241 Completed - Iodine Deficiency Clinical Trials

Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid - Phase 1

DFS-IoFA-1
Start date: June 26, 2023
Phase:
Study type: Observational

The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status and thereby reduce the risk of neural tube defects (NTDs), which are highly prevalent in Ethiopia. The project will be conducted in two phases. The purpose of Phase 1, described herein, is to complete formative research in preparation for a community-based, randomized trial, which will be carried out in Phase 2. The objectives of Phase 1 are to: 1) assess the hematological condition and nutritional status with respect to folate, iodine, and other micronutrients among non-pregnant women of reproductive age (WRA) in the study communities, and 2) measure discretionary salt and dietary folate intakes of the women and their households.

NCT ID: NCT05788172 Completed - Anemia Clinical Trials

Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

MBL_Loss
Start date: March 1, 2023
Phase:
Study type: Observational

It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.

NCT ID: NCT05786573 Recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia

A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

Start date: September 25, 2023
Phase: Phase 3
Study type: Interventional

This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

NCT ID: NCT05784870 Recruiting - Clinical trials for Hematological Malignancy

A Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors

Start date: February 7, 2023
Phase: Phase 3
Study type: Interventional

Cancer-related anemia (CRA) is one of the common accompanying diseases of malignant tumors. In 2019, a cross-sectional survey on the anemia status of 7324 malignant tumor patients in 97 hospitals in China found that the incidence of CRA was about 49.24%. 92.84% of the patients have not been given enough attention and effective treatment. According to the European Oncological Anemia Survey, CRA has the highest incidence in leukemia patients, followed by lymphoma/myeloma. CRA not only leads to a decline in the quality of life of patients, but also reduces the sensitivity to radiotherapy and chemotherapy, and also causes hypoxia in tumor tissue, which affects the prognosis of patients as an independent factor. At present, the treatment of CRA mainly includes blood transfusion therapy, erythropoiesis-stimulating agent (ESA) therapy, iron supplementation, etc. Conventional oral iron has low bioavailability and strong gastrointestinal irritation. Although intravenous iron can quickly replenish iron, excessive iron supplementation is prone to iron overload. Less acceptable. Shengxuening Tablets are derived from silkworm excrement. The main components of iron chlorophyllin and chlorophyll derivatives are very similar in structure to heme, and can be directly absorbed by small intestinal mucosal cells, effectively supplementing the iron elements required in the process of hematopoiesis. The investigators found that Shengxuening Tablets can increase the number of peripheral blood cells in mouse models of myelosuppression, improve bone marrow morphology, reverse the decrease in body weight and spleen index, and increase the levels of serum erythropoietin and granulocyte-macrophage colony-stimulating factor . Real-time fluorescent quantitative PCR and Western blot analysis showed increased expression levels of stem cell factor (SCF), JAK2 and STAT3 in the liver. These results indicated that Shengxuening Tablets promoted the recovery of hematopoietic function in myelosuppressive models by increasing the secretion of hematopoietic factors and activating the JAK2/STAT3 pathway. Therefore, in order to further confirm the preventive effect, effectiveness and safety of Shengxuening Tablets in the treatment of anemia in patients with hematological tumors complicated with anemia, this clinical trial was designed.

NCT ID: NCT05773586 Recruiting - Anemia Clinical Trials

A Study to Investigate the Safety, Pharmacokinetics and Efficacy of APG-5918 in Healthy Subjects or Anemic Patients

Start date: March 13, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.

NCT ID: NCT05768997 Recruiting - Anemia Clinical Trials

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Start date: March 1, 2023
Phase: Phase 3
Study type: Interventional

This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.

NCT ID: NCT05762380 Completed - Clinical trials for Iron Deficiency Anemia

Effect of Iron Supplements on the Growth of Enteric Pathogens

Start date: June 14, 2022
Phase: N/A
Study type: Interventional

Iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. Because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. However, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from women of reproductive age following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens, and outcome measures will be determined following in vitro fecal fermentation.

NCT ID: NCT05757570 Recruiting - Clinical trials for Immune Thrombocytopenia

An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias

RUBY-4
Start date: July 3, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.

NCT ID: NCT05757310 Recruiting - Clinical trials for Refractory Severe Aplastic Anemia

A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Patients With Refractory or Recurrent Severe Aplastic Anemia

Start date: August 1, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial evaluates the safety and feasibility of using a reduced-intensity regimen of cyclophosphamide, pentostatin, and anti-thymocyte globulin prior to a CD4+ T-cell depleted haploidentical hematopoietic cell transplant (haploHCT) for the treatment of patients with severe aplastic anemia that does not respond to treatment (refractory) or that has come back (recurrent). Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid. It may also lower the body's immune response. Pentostatin blocks a protein needed for cell growth. Anti-thymocyte globulin is an immunosuppressive drug can destroy immune cells known as T-cells. HaploHCT transfers blood-forming stem cells from a healthy partially-matched donor to a patient. Administering a regimen of cyclophosphamide, pentostatin, and anti-thymocyte globulin before haploHCT may help make room for the new, healthy cells and may reduce the risk of graft versus host disease.

NCT ID: NCT05752955 Recruiting - Hypertension Clinical Trials

SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India. The main questions it aims to answer are: - Can screening of pregnant and postpartum women using the SMARThealth Pregnancy intervention decrease anaemia prevalence at 1 year after birth? - Can the SMARThealth Pregnancy intervention improve postnatal testing after a pregnancy affected by hypertension and diabetes? Participants in the intervention group will be screened by their community health worker at several timepoints during pregnancy, and in the first year after birth using the SMARThealth Pregnancy tablet App. The community health worker will ask about each woman about her medical and obstetric history, then measure her blood pressure, haemoglobin (using a point of care device), and offer a referral for a glucose tolerance test when indicated. Women who screen positive for anaemia, hypertension or diabetes will be given advice and referred to the primary care doctor. The primary care doctor will have a complimentary tablet app to facilitate electronic referral and evidence-based prescribing when indicated. The comparison group will have usual antenatal and postnatal care.