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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT04626414 Recruiting - Clinical trials for Anemia, Iron Deficiency

Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers

Start date: September 28, 2020
Phase: Phase 1
Study type: Interventional

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.

NCT ID: NCT04587141 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial

RIDARTII
Start date: January 1, 2020
Phase: Phase 3
Study type: Interventional

Anemia is the most common extraintestinal manifestation of inflammatory bowel diseases (IBD), Although most cases of anemia in IBD are due to iron deficiency, many patients with iron deficiency anemia (IDA) are not treated with iron supplementation. In addition, it has not been firmly established which iron supplementation modality provides the best results in terms of effectiveness and safety. In the present study the investigators will compare the effectiveness and efficacy of three iron supplementation modalities in IBD-associated IDA. There will be two arms of parenteral (iv) iron supplementation (ferric carboxymaltose and ferric gluconate) and one arm of oral supplementation (sucrosomial iron). Primary objective of the study is is to compare the efficacy of oral iron with that of the iv iron supplementation regimens. The primary outcome is measured as the percentage of patients responsive to iron supplementation. Response is defined by Hb normalization or by an Hb increase ≥2 g/dL by week 8 from start of therapy. As secondary objectives the influence of anemia and its treatment on fatigue, quality of life, hospitalizations, additional outpatient visits, number of endoscopic examinations; further treatments and relative side effects will be evaluated.

NCT ID: NCT04464850 Recruiting - Anemia Clinical Trials

Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

IVO-IRON
Start date: July 29, 2020
Phase: Phase 3
Study type: Interventional

This study is aim to compare the efficacy of intravenous versus oral iron therapy regarding the hemoglobin levels, iron status and erythropoietin dosage in maintenance hemodialysis patients

NCT ID: NCT04351607 Recruiting - Clinical trials for Anemia, Iron-Deficiency

Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.

Preop Iron
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

To prove, if preoperative elective anemic patients improve their hemoglobin levels within 3-6 weeks preoperativly after daily oral dietary supplementation of 60mg sucrosomal iron.

NCT ID: NCT04335058 Recruiting - Clinical trials for Iron Deficiency Anemia

Lactoferrin in Treatment of Fe Deficient Anemia In Cirrhosis

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Iron deficiency and altered homeostasis due to inflammation and decreased iron utilization are main factors involved in anemia in liver disease. Lactoferrin is a first line defence protein for protection against microbial infections and subsequent development of systemic disease as seen with systemic inflammatory response syndrome (SIRS) and sepsis. Lactoferrin with iron has been shown to be efficacious with anemia in chronic disease, in pregnancy and in cancer patients with fewer side effects than oral iron alone. High exposure to iron is associated with increased inflammation which is associated with worse cardiovascular outcomes. Lactoferrin can help reduce the total iron dose and hepatic inflammation.

NCT ID: NCT04278651 Recruiting - Pregnancy Related Clinical Trials

Early Antenatal Support for Iron Deficiency Anemia

EASI-A
Start date: September 29, 2021
Phase: Phase 4
Study type: Interventional

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

NCT ID: NCT04268849 Recruiting - Clinical trials for Iron Deficiency Anemia

Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient

Start date: February 27, 2020
Phase: Phase 3
Study type: Interventional

Given the limited long-term effectiveness of traditional weight loss methods, bariatric surgery is increasingly becoming the preferred option for sustained weight loss. With the ascendancy of the laparoscopic approach, the two most common procedures are the Roux-en-Y gastric bypass (RYGB) and the vertical sleeve gastrectomy (VSG). Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient. The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for its caustic effects on the gastric mucosa causing gastric irritation, nausea, epigastric discomfort and constipation. These debilitating symptoms lead to poor adherence and lower long and short-term efficacy. Furthermore, iron absorption from oral iron supplements when taken with food in patients with low iron stores ranges from 2 to 13% and without food 5 to 28%. An alternative and more effective method of iron replenishment is the use of intravenous iron. A litany of published trials, without contradiction, show marked superiority of intravenous iron in improving hemoglobin concentrations and iron parameters when compared to historical controls. Nonetheless, the current recommendations of the American Society of Metabolic and Bariatric Surgery nutritional guidelines, state that oral iron supplementation for IDA is the recommended first line of treatment. Studies are lacking that compare the efficacy of oral versus intravenous (IV) iron therapy for the treatment of IDA in the post-bariatric surgical patient. The aim of our study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of IDA in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures. The primary outcome will be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify (based on inclusion/exclusion criteria), have an open-label IV iron treatment and will be followed with the same evaluations used after the first IV iron treatments.

NCT ID: NCT04205266 Recruiting - Clinical trials for Anemia, Iron Deficiency

IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding

Start date: February 14, 2020
Phase: Phase 4
Study type: Interventional

This study investigates whether intravenous (IV) iron [Feraheme (ferumoxytol) injection)] is a better treatment than oral iron pills (ferrous sulfate) for correcting anemia in women who have heavy menstrual bleeding and anemia. Investigators will study whether women's blood counts respond better, respond more quickly, and if women prefer the IV treatment or the oral treatment. Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions. Investigators will then check whether and how quickly the anemia improves, and survey participants on how satisfied they were with the treatment.

NCT ID: NCT04008147 Recruiting - Clinical trials for Gestational Diabetes

Hepcidin and Glucose Metabolism

Start date: July 3, 2019
Phase: N/A
Study type: Interventional

Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented. Whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.

NCT ID: NCT03957187 Recruiting - Atrial Fibrillation Clinical Trials

Prevalence and Clinical Associates of Iron Deficiency in Patients With Atrial Fibrillation

AID-AF
Start date: October 1, 2019
Phase:
Study type: Observational

To estimate the prevalence of iron deficiency (ID) in patients with atrial fibrillation