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Iron Overload clinical trials

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NCT ID: NCT04198545 Active, not recruiting - Iron Overload Clinical Trials

Ethnic Differences in Iron Absorption (FeGenes)

FeGenes
Start date: August 1, 2019
Phase:
Study type: Observational

This study aims to; 1) investigate population differences in iron absorption between East Asians and Northern Europeans; 2) assess population differences in hormonal and biochemical determinants of Fe absorption between East Asians and Northern Europeans; and 3) to investigate genetic contributions to Fe absorption, Fe status and Fe regulatory hormones between East Asians and Northern Europeans.

NCT ID: NCT02425956 Active, not recruiting - Iron Overload Clinical Trials

Non-invasive Quantification of Liver Iron With MRI

Start date: April 2015
Phase: N/A
Study type: Interventional

This study is being conducted to build a library of prospectively collected clinical data from subjects with iron overload examined with commercially available MRI devices. This data library is intended for use in future engineering development and other research activities, including future regulatory submissions. Data from human subjects is required to develop and test Magnetic resonance (MR) reconstruction techniques that can provide quantitative information about tissue properties, such as volumetric fat and iron concentrations. Collection of MR data and corresponding quantitative liver iron concentration (LIC) data is necessary for development of MR techniques that can show both overall and regional iron concentrations of in vivo tissues. These techniques may provide viable alternatives to invasive and expensive conventional liver biopsy and to less accurate serum biomarker testing, potentially benefiting future clinical patients with iron overload. MR image data and corresponding quantitative data about serum and liver iron levels will be collected from each subject in this study. These datasets are considered suitable for future development and testing of MR reconstruction software, including MR reconstruction algorithms developed by General Electric Healthcare (GEHC) to use Longitudinal relaxation rate equal to the reciprocal of T2 relaxation time (1/T2) (R2) techniques to assess LIC. To achieve a sufficiently diverse library for future testing, MRI data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GEHC IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan® Specialized Reconstruction Service guidelines (Resonance Health, Claremont, AU). Quantitative hematologic (serum ferritin) based on blood testing and FerriScan® Analysis Service LIC reports will be collected for each subject.

NCT ID: NCT01443195 Active, not recruiting - Iron Overload Clinical Trials

Iron Metabolism in Small Pre Term Newborns

Start date: October 2011
Phase: N/A
Study type: Interventional

Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels. Iron overload remains a significant concern in preterm infants because they have low levels of iron-binding proteins and immature antioxidant systems. The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the iron supplementation practice for VLBW preterm infants as implemented in the Neonatal Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.

NCT ID: NCT00999349 Active, not recruiting - Iron Overload Clinical Trials

Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Start date: March 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.

NCT ID: NCT00907283 Active, not recruiting - Iron Overload Clinical Trials

Ferrochelating Treatment in Patients Affected by Neurodegeneration With Brain Iron Accumulation (NBIA)

Start date: November 2008
Phase: Phase 2
Study type: Interventional

This trial is a multicenter, unblinded, single-arm pilot study, lasting one year (plus one year extension Amendment n.3 25 August 2009, plus two years follow-up Amendment n.7) , to evaluate the efficacy and safety of the chelator therapy with deferiprone on cerebral iron accumulations. The drug will be administered in the dosage of 15 mg/kg twice daily. The safety and tolerability of the drug will be evaluated by measuring hemochrome every seven days with leukocyte formula count. At 3, 6 and 12 months from the start of treatment, a neurological evaluation will be performed using several specific evaluation scales (International Cooperative Ataxia Rating Scale (ICARS); Unified Parkinson's Disease Rating Scale (UPDRS); Burke-Fahn-Marsden (BFM)). Every 6 months of treatment, a brain magnetic resonance image (MRI) aimed at measuring iron overload quantitatively, if possible.