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Iron Deficiency clinical trials

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NCT ID: NCT03181451 Completed - Iron-Deficiency Clinical Trials

Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency

Start date: March 14, 2017
Phase: Phase 1
Study type: Interventional

The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.

NCT ID: NCT03156712 Completed - Iron-deficiency Clinical Trials

Iron Absorption From Iron-enriched Aspergillus Oryzae

BIEFS
Start date: May 29, 2013
Phase: N/A
Study type: Interventional

Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.

NCT ID: NCT03079518 Completed - Iron Deficiency Clinical Trials

Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency

Iron Turtle
Start date: March 10, 2017
Phase: Phase 2
Study type: Interventional

Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up ("main") study.

NCT ID: NCT03074591 Completed - Heart Failure Clinical Trials

Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction

FAIR-HFpEF
Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe

NCT ID: NCT03071497 Completed - Anemia Clinical Trials

Non-invasive Diagnostics of Iron Deficiency in Surgical Patients by Measuring Zinc Protoporphyrin-IX

Start date: March 3, 2017
Phase:
Study type: Observational

- In approx. 40% of the incidences anemia is caused by iron deficiency (= ID). In turn, preoperative iron-deficiency anemia (= IDA) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion. - A successful preoperative treatment of IDA via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. This however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure. - Measured in blood zinc protoporphyrin-IX (= ZnPP) is an established parameter to detect ID. - This study aims to evaluate a prototype device detecting ZnPP non-invasively in the intact oral mucosa of surgical patients. - Results from the non-invasive measurement will be compared to reference measurements of ZnPP from residual blood samples (HPLC analysis) as well as to other parameters including Hb level and iron profile (MCH [= mean corpuscular hemoglobin], MCV [= mean corpuscular volume], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, CRP).

NCT ID: NCT03055559 Completed - Iron Deficiency Clinical Trials

Trial Protocol GlobiFer - Oral Iron Repletion

TPG
Start date: June 2016
Phase: N/A
Study type: Observational

The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.

NCT ID: NCT03037931 Completed - Heart Failure Clinical Trials

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

HEART-FID
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

NCT ID: NCT03036462 Completed - Iron Deficiency Clinical Trials

Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

FAIR-HF2
Start date: February 7, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

NCT ID: NCT03030716 Completed - Clinical trials for Iron Deficiency Anemia

Multiple Daily Condensed Tannin Supplementation and Iron Bioavailability: The Tannin Dose Response Trial

Start date: June 25, 2016
Phase: N/A
Study type: Interventional

Tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral complexes, and have thus been termed 'antinutritional.' Despite this, there is evidence that adaptation to similar antinutritional factors is possible when consumed over time. Limitations in current studies include short (single meal) duration, and use of incongruent tannin types from the condensed tannins that are commonly consumed. If adaptation to tannins does happen, it may be due to salivary proline-rich proteins, which have been found to be protective of iron status in animal models. The primary objectives of this study are: 1) To determine whether condensed tannins impact iron bioavailability or status when consumed in multi-dose, multiple daily supplements and 2) to test whether salivary protein production may impact iron bioavailability with tannin supplementation. Secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption. The study has been conducted in an iron absorption study of 11 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95% proanthocyanidin rich grape seed extract before and after regular, three times daily supplementation for four weeks. Each participant consumed all three concentrations of supplement over the 26-week study, with a two-week washout between interventions. Direct iron absorption was measured using area under the curve. Iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on HPLC. Astringency testing was conducted at the end of each meal challenge. Iron absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison by least significant differences. Pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability. The present study will provide important information regarding the approximate influence of condensed tannin consumption on iron bioavailability and storage over time, at different doses. Data will also help to delineate possible physiological mechanisms underlying tannin adaptation and possible ways to detect individuals who better adapt than others.

NCT ID: NCT03030703 Completed - Clinical trials for Iron Deficiency Anemia

Cystatin SN Binds to Phytic Acid and Predicts Non-heme Iron Bioavailability

Start date: November 11, 2016
Phase: N/A
Study type: Interventional

Phytic acid is a known inhibitor of iron bioavailability, although long term studies have suggested possibly exaggerated findings compared to single meal studies, pointing to phytic acid adaptation over time. Salivary proline-rich proteins have been found to reduce tannin-iron chelation, but studies have not explored changes in salivary proteins that may result in phytic acid adaptation. The primary objectives of this study are: 1) To determine whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test whether salivary protein production may impact iron bioavailability with phytic acid supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption. The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 350 mg phytic acid before and after regular, three times daily supplementation for four weeks. Direct iron absorption was measured using area under the curve. Iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison by least significant differences. Pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability. The present study will provide important information regarding the approximate influence of phytic acid consumption on iron bioavailability and storage over time in regards to salivary proteins. It will also give context to the role of salivary proteins with phytic acid consumption over time. Data will also help to delineate possible physiological mechanisms underlying phytic acid adaptation and possible ways to detect individuals who better adapt than others.