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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT06027801 Recruiting - Clinical trials for Iron Deficiency Anemia

Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity

Start date: September 6, 2023
Phase: N/A
Study type: Interventional

Iron deficiency (ID) anaemia (IDA) is a global public health problem, with the highest prevalence in Africa and in South-East Asia. While immunization programs have achieved high global coverage, vaccines often underperform in low- and middle-income countries (LMIC). The cause remains uncertain, but undernutrition, including ID, likely plays a role. Our recent in vitro and in vivo studies have shown the importance of iron status in adaptive immunity and vaccine response. Hypoferremia blunted T cell, B cell, and neutralizing antibody responses to influenza virus infection in mice, allowing the virus to persist. Iron deficient anaemic Kenyan women receiving intravenous iron at time of vaccination had a better immune response to the first dose of the ChAdOx Coronavirus 19 (COVID-19) vaccine and yellow fever vaccine. Japanese encephalitis and typhoid fever are endemic in Thailand. Vaccines are available but show variable efficacy. Whether ID impairs adult vaccine response to the live attenuated Japanese encephalitis (JE) and the Typhoid Vi polysaccharide (Vi-PS) vaccine and whether iron repletion via iron fortification improves vaccine response is uncertain. The objective of this study is to assess whether IDA in Thai women impairs immune response to the JE and the Typhoid Vi-PS vaccine and whether fortification iron improves their response. In this double-blind randomized controlled trial, IDA women will be assigned to two study groups: group 1 (fortification group) will receive iron-fortified biscuits (15mg iron as ferrous fumarate) for 56 days; group 2 (control group) will receive non-fortified biscuits for 56 days. All women will receive live attenuated JE and Typhoid Vi-PS vaccine on study day 28. Vaccine response will be measured 28 days after vaccination (on day 56) in both groups.

NCT ID: NCT06021171 Completed - Clinical trials for Iron Deficiency Anemia

Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics

Start date: August 15, 2021
Phase: N/A
Study type: Interventional

Iron deficiency (ID) is the most common micronutrient deficiency worldwide, and poor iron bioavailability is a major cause. While 30% of female athletes are affected by ID, and its consequences are highly relevant to athletic performance, ID affects women and children around the world with consequences just as relevant, if not more so (e.g. school performance, work capacity and thus wage earning). With poor iron absorption being a cause of ID in active women, it is especially important to discover simple ways to improve iron (Fe) uptake. While some studies have suggested that consumption of prebiotic fiber may improve Fe absorption in animal models, there have been few studies examining the effects of synbiotic supplementation (consumption of both a prebiotic and probiotic that work together) on Fe uptake in adult females (athletes and non-athletes). A recent pilot study demonstrated a substantial improvement in Fe uptake in female athletes after 4 and 8 weeks of synbiotic supplementation compared to placebo during Fe repletion with a low dose of ferrous sulfate (FeSO4). If synbiotic supplementation can improve the Fe bioavailability of FeSO4 (which is ~30%) in ID women during repletion of Fe status, it could possibly improve the Fe bioavailability of non-heme Fe sources, as well as mixed meals. Research Question: What is the effect of synbiotic supplementation (a supplement containing a prebiotic + a probiotic), compared to prebiotic supplementation or a placebo, on Fe uptake and the gut microbiome in ID athletes during low-dose Fe repletion? Hypothesis: In the proposed study, we hypothesize that synbiotic supplementation along with Fe repletion with a low dose of FeSO4 will have greatest impact on athletes' Fe uptake due to alterations in the microbiome, which will be assessed.

NCT ID: NCT06012760 Recruiting - Anemia Clinical Trials

The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

CIPAT
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Previous studies have shown that perioperative intravenous iron has a beneficial effect on patients with perioperative anaemia. To assess whether a combined iron supplementation regimen can reduce perioperative allogeneic blood transfusions in patients with iron deficiency anaemia undergoing major cardiac surgery under haemodynamic anaesthesia, a multicentre randomised clinical trial (CIPAT study) will be conducted. In the CIPAT study, patients undergoing elective major cardiac surgery under general anaesthesia will be randomly allocated to a control group and a combined iron supplementation group. Patients in the combined iron supplementation group will receive a combination iron supplementation regimen of iron sucrose in combination with Human Erythropoietin and vitamin C three times in the week prior to surgery, while patients in the control group will receive the same dose of placebo three times in the week prior to surgery. The primary endpoint is the volume of allogeneic erythrocyte infusion from the start of surgery to 5 days postoperatively. It is hypothesised that patients in the combined iron supplementation group will have fewer perioperative allogeneic red blood cell transfusions than those in the control group.

NCT ID: NCT06009575 Completed - Anemia Clinical Trials

Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study

Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to test the impact of a local culture-based nutritional education intervention on IST consumption compliance among female adolescents in the Ogan Komering Ilir Regency. The main questions it aims to answer are: a To identify information for the development of a local culture-based nutrition education model and to build a ready-to-implement local culture-based nutrition education model. b. To evaluate the implementation of the Anemia Prevention and Control Program among female adolescents in Ogan Komering Ilir Regency. c. To test the impact of the local culture-based nutrition education model on the improvement of knowledge, attitude, and IST consumption compliance among female adolescents. Participants will received IST and local culture-based nutrition education. Researchers will compare control group received IST as the Ministry of Health's program for the prevention of anemia with a subsidy for providing IST

NCT ID: NCT05992116 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction

Start date: September 1, 2023
Phase:
Study type: Observational

A significant percentage of patients with heart failure and reduced ejection fraction (HFrEF) or mildly reduced ejection fraction (HFmrEF) have iron deficiency who are symptomatic. This is independently associated with bad quality of life, low functional capacity, lower quality of, life and increased mortality. The prevalence of iron deficiency in HFrEF and HFmrEF patients in Jordan has not been studied in the past.

NCT ID: NCT05991128 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

COREVIVE-HFpEF
Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.

NCT ID: NCT05990166 Recruiting - Iron Deficiency Clinical Trials

Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age

Start date: April 27, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to determine if taking a mineral-enriched powder can raise blood iron levels compared to a placebo powder in reproductive-aged women with iron deficiency. The main questions it aims to answer are: - Does the mineral-enriched powder raise blood iron levels compared to a placebo powder in women when it is taken every day for six months? - How many participants still have iron deficiency after six months of taking the mineral-enriched powder compared to a placebo powder? Participants in this clinical trial will drink the mineral-enriched powder containing ferrous iron and zinc sulphate monohydrate or a placebo powder mixed with 1 litre of water daily for six months. The placebo is a look-alike substance that does not contain active ingredients (iron and zinc). Participants will also have to: - Complete an online "study diary" every two weeks for six months - Provide a blood sample once a month for six months - Attend three in-person visits with a researcher, at enrolment (baseline), midline (three months), and endline (six months) - Complete three sets of online questionnaires (following each in-person visit) - Complete three sets of dietary assessments (following each in-person visit) - Provide three stool samples (following each in-person visit)

NCT ID: NCT05985070 Recruiting - Clinical trials for Iron Deficiency Anemia

Evaluating the Effectiveness of Various Iron Salts and Carrier Systems in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferrous gluconate, ferrous fumarate, ferric maltose and ferric pyrophosphate. Each salt differs in elemental iron content and potential side effects, allowing for tailored treatment based on individual patient needs and tolerability. Moreover, advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.

NCT ID: NCT05971732 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)

COREVIVE-HFrEF
Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.

NCT ID: NCT05960227 Active, not recruiting - Acute Kidney Injury Clinical Trials

Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury

Start date: January 6, 2023
Phase: Phase 2
Study type: Interventional

This clinical trial aims to carry out research on the effect on hemoglobin and renal function of intravenous administration of iron dextran as a repletion strategy in patients with iron deficiency anemia and acute kidney injury, in which the patient may benefit from this drug as it is expected to correct anemia, ferropenia and renal function parameters, when compared with a control group (placebo), the safety of the drug will also be assessed by recording adverse effects. The investigators will point out with the patient the risks and benefits of their inclusion in this type of study and the investigators will attend to all the doubts that are generated, as well as immediately report to the research ethics committee any serious adverse effects. The results will be presented at national and international conferences and will be published in high-impact journals, and will also be the subject of a thesis to achieve the title of specialist.