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Iron Deficiency clinical trials

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NCT ID: NCT06427343 Recruiting - Heart Failure Clinical Trials

The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency

IRONDOSE
Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.

NCT ID: NCT06285799 Recruiting - Iron-deficiency Clinical Trials

Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women

Start date: March 5, 2024
Phase: Phase 3
Study type: Interventional

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient, but otherwise healthy premenopausal women over 12 weeks.

NCT ID: NCT06270498 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 14, 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: NCT06115122 Recruiting - Clinical trials for Cardiovascular Diseases

PEPPI Study: Identification of Women at Risk for Placental Dysfunction

Start date: February 15, 2022
Phase:
Study type: Observational [Patient Registry]

The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a Finnish general population. Condition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome

NCT ID: NCT06080555 Completed - Iron Deficiency Clinical Trials

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia

Start date: October 9, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anaemia under fasting condition. The main questions it aims to answer are: - [Question 1] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection (trade name: Ferinject®, strength: 10 mL: 500 mg [calculated by iron]) held by Vifor France? - [Question 2] Is it safe for patient to take ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of patients in each group,to receive test product or reference product according to the protocol below. - Dosing on D1: Group T (Test product) Group R (Reference product) - PK blood sample collection - Safety evaluation

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: NCT06014983 Recruiting - Pregnancy Clinical Trials

Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy

EASE-Iron
Start date: April 12, 2024
Phase: N/A
Study type: Interventional

This two-arm, double-blind randomized clinical trial will recruit 208 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until ~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline and again at ~37 weeks gestation to assess how different forms of iron impact body iron stores. Rectal swabs will also be taken at baseline and ~37 weeks gestation to detect presence of harmful bacteria in the gut and quantify their abundance. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.

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: 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.