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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT06437080 Active, not recruiting - Clinical trials for Iron Deficiency Without Anemia)

Hypoferritinemia Without Anemia Among Reproductive Age Females

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to compare the treatment outcomes of oral iron supplementation (Group A) versus Intravenous (IV) iron supplementation (Group B) versus normal diet (no treatment) (Group C) on the serum ferritin level and to determine the outcomes in the severity of symptoms of HWA, among reproductive age females (age 18-45) with hypoferritinemia without Anemia (HWA), after four months of the start of the intervention. The main questions it aims to answer are: 1. What are the main determinants of HWA? 2. There is no difference/ difference in the treatment outcomes after intervention 3. There is no difference/ difference in the severity of symptoms of HWA after intervention. Participants will: - Randomly divided into 3 groups (A, B and C) to receive treatment. - 100 patients will be allocated to each of the three study groups i.e., group A, B and C. The participants of Group A will get oral Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron, 100 mg (Fersip) daily for three months, participants of group B will get IV Ferric Carboxymaltose (Ferinject) for 03 months (3 doses) and Group C will remain on their normal diet, - Visit the clinic once every 1 month for 03 months for doses and assessment of symptoms and adverse events will be done. - All 03 groups will be called after one month of the last dose and the blood samples will be taken to evaluate the effect of iron supplementation on serum ferritin levels and the severity of symptoms to assess the effectiveness of the intervention.

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.

NCT ID: NCT05545527 Active, not recruiting - Child Development Clinical Trials

Neuroimaging Ancillary Study

Start date: February 21, 2023
Phase:
Study type: Observational

As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.

NCT ID: NCT05544513 Active, not recruiting - Dysbiosis Clinical Trials

Oral Iron Supplementation for Patients With Chronic Kidney Disease

Start date: August 1, 2022
Phase: Phase 2
Study type: Interventional

The hypothesis of this research is that oral iron prescribed in a single dose in alternate day could mitigate the side effects with regard to intestinal microbiota, inflammation, oxidative stress and improve the hematological profile when compared to daily oral iron prescription

NCT ID: NCT05504863 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study

RAPIDIRON-KIDS
Start date: October 11, 2022
Phase:
Study type: Observational

As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.

NCT ID: NCT05500014 Active, not recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Altitude on Iron Absorption in Iron Depleted Women

PotatoAlt
Start date: August 20, 2022
Phase: N/A
Study type: Interventional

One of the most common nutritional deficiencies worldwide is iron deficiency. Iron deficiency is considered the main cause of anaemia in developing countries, including those in South America. The most recent surveys report that the prevalence of anaemia is as high as, 40 and 25% in Peru. Populations living at higher altitudes may have higher iron requirements, as body iron is naturally increased in long-term high-altitude residents to compensate for the lower oxygen in the air at high altitudes. However, the effects of chronic exposure to high altitude on iron status, body iron compartments and dietary iron requirements are incompletely understood. The primary objective of the proposed research is to determine iron bioavailability of iron from biofortified potatoes at different altitudes in populations of Andean descent. Human trials will be undertaken with volunteers in the Huancavelica region of Peru (elevation: 3676 meters) as well as in Lima (elevation close to sea level). The aim is to assess the effect of altitude on the absorption from a promising iron biofortified potato cultivar. These trials require incorporation of iron stable isotopes into the meals of the bio fortified potato and the analysis of the isotopes in subsequent blood (red blood cells) samples. Stable iron istotopes are considered the golden standard to assess human iron absorption and can be safely used as tracer substances in humans. The objective of the study is to compare, in volunteer females of childbearing age, the bioavailability of iron from bio-fortified potatoes in two locations of different altitudes and quantify the effect of altitude on iron bioavailability from a potato meal consumed over 5 consecutive days.

NCT ID: NCT05085275 Active, not recruiting - Clinical trials for Renal Insufficiency, Chronic

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

FRONTIER
Start date: March 30, 2022
Phase: Phase 3
Study type: Interventional

A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.

NCT ID: NCT04994275 Active, not recruiting - Clinical trials for Postoperative Complications

Impact of Iron Deficiency on the Incidence of Postoperative Infections

CARIPO
Start date: November 3, 2021
Phase:
Study type: Observational

Iron deficiency is a common state during the perioperative period. Data from literature do not allow us to conclude on how perioperative iron deficiency influences postoperative infections occurrence. This prospective observational study aims to assessed the postoperative infections incidence according to the preoperative iron-stock status.

NCT ID: NCT04778072 Active, not recruiting - Clinical trials for Iron Deficiency Anemia

A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron. Subjects with intolerance and treatment failure due to oral iron (male and female subjects, aged 18 to 55 years, with mild to moderate iron deficiency, with or without anaemia) are eligible. Sixty subjects are randomised into three groups (14 mg elemental iron, 25mg elemental iron and 50mg elemental iron daily). The primary objective is to assess adherence/persistence (including using pill counts). Secondary objectives are to assess gastrointestinal tolerability, haematological efficacy and health related quality of life.

NCT ID: NCT04343170 Active, not recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction

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

Scoliosis is a condition in which there is curvature of the spine occurring in the lateral plane. It occurs in structural forms, characterized by a fixed curve, and "functional" forms, characterized by a flexible or correctable curve. By anatomic necessity, this lateral deviation is associated with vertebral rotation, such that when this deformity occurs in the thoracic spine, a chest wall deformity, or "rib hump," develops. Often there is a primary structural curve with an adjacent secondary compensatory curve. Most cases of structural scoliosis are idiopathic and have their onset in early adolescence. Females are affected more often than males, and their curvature is more likely to worsen. Lumbar fusion surgery is usually associated with massive blood loss. In clinical practice the surgeon might measure the visible peri-operative bleeding including intra- and post-operative drainage, but ignore blood component penetration into the tissues, residual blood in vertebral canal and loss due to haemolysis, which are also known as hidden blood loss. In patients with adolescent idiopathic scoliosis (AIS), surgical treatment involves a posterior approach with multi-segmental pedicle screw fixation. Although this procedure is generally considered safe with few surgical complications, there are considerable variations in fusion length, surgical time, and the extent of soft-tissue exposure. Consequently, perioperative blood loss can be substantial, and the use of intraoperative and postoperative RBC transfusions are frequently required. Patient blood management (PBM) is an evidence-based, multidisciplinary approach developed over the last 10 years focusing on improving patient outcomes as well as reducing the use of RBC transfusions. PBM includes several preventive measures to manage bleeding risks, reduce iatrogenic blood loss, and modify decision thresholds for the appropriate administration of blood therapy. All patients for elective surgery in whom blood loss is expected to be > 500 ml should have their hemoglobin checked pre-operatively and be investigated if they are found to be anemic. In the general population, anemia is defined as a hemoglobin less than 130 g. in men and less than 120g. in women by the WHO. It was proposed that the cut-off value/trigger be changed to hemoglobin more than 130 g for both men and women. Women with hemoglobin levels between 120 and 129 g. are not considered to be anemic according to the WHO definition, leaving them at a potential disadvantage when undergoing major surgery