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Iron Deficiency clinical trials

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NCT ID: NCT03554668 Completed - Inflammation Clinical Trials

Systemic Inflammatory Response: Thiamine and Magnesium Status (Sir TaM Study)

SirTaM
Start date: January 15, 2018
Phase:
Study type: Observational

We wish to determine to what extent magnesium, thiamine and transketolase activity are affected by the Systemic Inflammatory Response (SIR). The knee arthroplasty model affords the ideal study design, as surgery generates an inflammatory response. Blood samples are drawn preoperatively and for up to four days post operatively, and again at three months post-operation.

NCT ID: NCT03542825 Completed - Iron-deficiency Clinical Trials

Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores [Sharma JB; et al., 2004]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection [ So¨lvell L; et al., 1970].

NCT ID: NCT03541213 Completed - Iron-deficiency Clinical Trials

Impact of Iron Deficiency and Its Correction on Mitochondrial Metabolism of the Cardiomyocyte (MitoCardioFer)

MitoCardioFer
Start date: January 23, 2019
Phase: N/A
Study type: Interventional

Iron is involved in essential functions of the body. It allows the transport of oxygen in the blood, via hemoglobin, at the muscular level, via myoglobin, and it is also involved in cellular metabolism in general, in particular for the production of ATP at the mitochondrial level, within the cytochromes and iron-sulfur proteins of the respiratory chain. Recently, iron deficiency has been identified as an important prognostic factor in heart failure patients. Iron therapy improves symptoms and physical performances of heart failure patients, even in the absence of anemia. As a result, the correction of iron deficiency is now proposed as one of the therapies for heart failure. However, the pathophysiology of the association between cardiac dysfunction and iron deficiency is still poorly understood. The investigators previously developed a mouse model of iron deficiency without anemia, in which the investigators observed impaired physical performances, a decrease of left ventricular ejection fraction, and a decrease in mitochondrial complex I activity. These abnormalities were normalized after iron injection. These animal data suggest that iron deficiency is responsible for left ventricular dysfunction secondary to mitochondrial I complex abnormalities, and that iron therapy corrects them. Iron deficiency is very common in the preoperative period of cardiac surgery, affecting 40 to 50% of patients. During this surgery, it is possible to perform a myocardial biopsy without risk to the patient. The purpose of this study is to verify in patients requiring valvular heart surgery, if iron deficiency is responsible for a decrease in mitochondrial complex I activity and a decrease in cardiac function during the perioperative period, and to verify whether iron treatment improves these abnormalities.

NCT ID: NCT03523455 Terminated - Iron-deficiency Clinical Trials

Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training

Start date: November 29, 2016
Phase: N/A
Study type: Interventional

Participants are required to undergo a screening and qualification before beginning the study. Once qualified, baseline testing is completed in the laboratory. This testing includes: body composition measurements, a blood draw, questionnaires, a VO2 max test, and a time to exhaustion trial. This testing is repeated during week 4 and week 12. At week 8, subjects complete a blood draw and questionnaires only. During the 12 week period, participants will follow an endurance exercise program in which they will train 4 days per week. This is a double-blind study in which participants are randomized into either the placebo or supplement group. They are instructed to ingest the supplement once a day at breakfast. Diet logs are also monitored throughout the duration of the study with the restriction of no red meat.

NCT ID: NCT03516734 Active, not recruiting - Iron-deficiency Clinical Trials

Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh

Start date: September 30, 2018
Phase: N/A
Study type: Interventional

We designed a double-blind, community-based, cluster-randomized control trial which will test to establish novel evidence on the efficacy of iron-fortified lentil in improving body Fe status of non-pregnant adolescents in rural Mymensingh district of Bangladesh. Lentils will be fortified with iron in the lab setting at the Crop Development Center (CDC) of the University of Saskatchewan in Canada. There will be three lentils based dietary intervention arm in this efficacy trial. Arm 1 will be intervened with iron-fortified lentils, Arm 2 will be non-iron fortified lentils, and Arm 3 arm will be the usual intake of lentil (no additional lentil). Arm 2 will be served as a comparison group and arm 3 will be served as control group. A total of 420 adolescent girls (including 20% drop-outs) - aged 10 - 17y; non-smoking, not pregnant, not breastfeeding, and generally healthy will be included in each arm - a total of 1260 adolescent girls in all three arms. Participating adolescents will be served thick preparation of cooked lentils (37.5gm raw lentil) 5 days a week for 85 feeding days (around 4+months). Socio-demographic characteristics, household food security status, and adolescent food habits will be collected at baseline and endline data point. Furthermore, venous blood will be collected to measure adolescents' Fe status at baseline, midline, and endline for 85 feeding days (5 days a week)- approx. 4+ months. In addition, Ravens Progressive Matrices will be used for non-verbal measurement of the cognitive ability of advanced observation and thinking skills specific to capacity for analyzing and solving problems, abstract reasoning, and the ability to learn of the adolescents. Both descriptive and inferential statistics will be used for this study. Serum ferritin level and cognitive performance is the primary outcome. The trial expects that the supplemental Fe from the iron-fortified lentils will improve body Fe status and cognitive performance after controlling for baseline Fe status and dietary Fe intake in this group of adolescent girls. The secondary outcome is the participants' anthropometries. Considering the amount of plant protein from lentils that need to be consumed to for the study, it is expected to have significant improvement in growth of the participants which will lead to increased productivity.

NCT ID: NCT03508466 Completed - Iron-deficiency Clinical Trials

Mechanism of Hypersensitivity Reactions to Iron Nanomedicines

Start date: October 1, 2017
Phase:
Study type: Observational

Iron deficiency is common and when oral treatment is not sufficient intravenous application is indicated. Hypersensitivity to intravenous iron nanomedicines is rare but does occur and little is known about the underlying mechanism but complement activation has been suggested. This is a purely exploratory study as it is not yet known whether in vitro complement activation can be stimulated by titration with iron preparations. These data will provide first empirical evidence of whether and to what extent complement activation occurs in this population.

NCT ID: NCT03484026 Completed - Iron Deficiency Clinical Trials

Safety and Tolerability of BioFe for Iron Deficiency Management

Start date: May 17, 2018
Phase: N/A
Study type: Interventional

This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.

NCT ID: NCT03457571 Completed - Clinical trials for Inflammatory Bowel Diseases

Clinical Observational Study: IBD Patients With Restless-legs-syndrome and Iron Deficiency Syndrome

Start date: February 1, 2014
Phase: N/A
Study type: Observational

Patients with inflammatory bowel disease, such as Crohn´s disease or ulcerative colitis, have recurring episodes of abdominal pain, diarrhea and loss of weight. Besides this other clinical symptoms are possible e.g. deficiency syndromes such as iron deficiency. Iron deficiency usually attended by symptoms like hair loss, pale skin, loss of concentration or fatigue. In some cases iron deficiency can lead to neurological manifestations such as restless-legs-syndrome (RLS). Restless legs syndrome is a neurological disorders which is accompanied by substantial urge to move legs or other parts of the body and unpleasant sensations. Aim of this study is to to investigate the prevalence of RLS in patients with inflammatory bowel disease and furthermore evaluate the effect of iron supplementation in patients with iron deficiency and concomitant RLS.

NCT ID: NCT03398681 Completed - Heart Failure Clinical Trials

Changes in Myocardial Iron After Iron Administration

Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

Recent studies have shown that treatment with intravenous iron in patients with iron deficiency (ID) and heart failure with reduced ejection fraction (HFrEF) improves symptomatology, functional capacity, quality of life, and decreases hospitalizations regardless of anemia. In addition, a decrease in myocardial iron content has been observed in patients with chronic HFrEF. This preliminary evidence has led to postulate that myocardial iron deficiency could play a direct role in the pathogenesis and progression of the disease. The investigators hypothesize that the repletion of myocardial iron would explain part of the benefit of this treatment. Thus, the investigators postulate that cardiac magnetic resonance (CMR) (T2* and T1-mapping sequences) will be sensible enough to detect changes in myocardial iron content as a result of intravenous iron administration, and that such changes will correlate with simultaneous changes in parameters of heart failure severity. In this double-blind 1:1 randomized study controlled by placebo the investigators aim to determine the changes in myocardial iron content after treatment with intravenous ferric carboxymaltose (FCM) by CMR at 7 and 30 days in patients with stable HFrEF and ID.

NCT ID: NCT03382275 Completed - Iron-deficiency Clinical Trials

EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations

EXPLAIN-IRON
Start date: January 16, 2018
Phase:
Study type: Observational [Patient Registry]

By describing the characteristics of iron deficiency (ID) patients treated with various oral or intravenous iron formulations and their outcomes, this registry will provide the medical community with important information to support treatment decisions for their patients regarding data on effectiveness, safety, tolerability, treatment persistence, quality of life, and therapeutic costs. This will ultimately support improvements to patient care, including the longā€term outcomes of patients with ID.