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Anemia, Iron Deficiency clinical trials

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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.

NCT ID: NCT03013439 Completed - Anemia Clinical Trials

Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

Start date: January 6, 2017
Phase: Phase 1
Study type: Interventional

The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

NCT ID: NCT03009578 Completed - Anemia Clinical Trials

Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia

Start date: February 1, 2017
Phase: Phase 3
Study type: Interventional

Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care programmes in numerous developing and underdeveloped nations. Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and postpartum hemorrhage are important causes of postpartum anemia

NCT ID: NCT03002090 Completed - Clinical trials for Iron Deficiency Without Anemia

Defining the Functional Role of Iron in Aerobic Training and Physical Performance

Start date: August 2014
Phase: N/A
Study type: Interventional

Iron deficiency is known to negatively impact physical performance, attention, and time spent doing physical activity. As a result, an iron deficient person must expend more energy to complete the same amount of work as someone who is healthy. Another interesting relationship has been observed between exercise training and iron status in that women who participate in exercise training often have higher rates of iron deficiency than sedentary women. ID is commonly treated using daily iron supplementation. However, it is currently unknown whether participating in regular exercise somehow impacts the effectiveness of iron supplementation. Iron deficient women who participate in exercise programs may potentially benefit less from iron supplementation than those who do not. Another common treatment for the symptoms of iron deficiency is the traditional Chinese herbal treatment, Ba-Zhen-Ke-Li (BZKL). While studies have shown that BZKL impacts expression of some iron-related proteins and increases endurance performance in rats, no studies have examined the efficacy of BZKL in improving iron markers or physical performance in humans. This study will compare the efficacy of BZKL in improving iron status and physical performance with that of ferrous sulfate supplementation. The Cornell research team will achieve these objectives in collaboration with colleagues at Kunming Medical University (KMU) in Kunming, China. A double-blind, randomized, placebo controlled study will be conducted by a Cornell graduate student at KMU. The subjects will be healthy women, age 18-26 years, attending KMU. Blood samples will be collected and analyzed for measures of iron). Subjects will be randomly assigned to receive 50 mg of ferrous sulfate (10 mg of elemental iron), 6mg of BZKL, or an identical placebo pill twice daily for 8 weeks. Subjects will be further randomly sub-divided to receive aerobic exercise training or no training during the 8-week supplementation period. At weeks 4 and 8, subjects will perform the same series of tests as was performed at baseline. The investigators hypothesize that: 1. the women who train and received iron will have smaller improvements in iron status than those who do not train 2. The women who receive iron and train will have greater improvements in physical performance than those who train and do not receive iron, and 3. The women who receive BZKL will improve their iron status or physical performance more than those who receive placebo.

NCT ID: NCT02998697 Completed - Clinical trials for Heart Failure, Systolic

Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

IRON5
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).

NCT ID: NCT02996786 Completed - Inflammation Clinical Trials

Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners

Start date: October 2016
Phase: N/A
Study type: Interventional

The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners.

NCT ID: NCT02990988 Completed - Iron Deficiency Clinical Trials

Microbiome of Donor Iron Deficient Study

Start date: January 2017
Phase:
Study type: Observational

The goal of this pilot study is to test whether the microbiome is affected by intravenous iron repletion.

NCT ID: NCT02989311 Completed - Anemia Clinical Trials

Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants

Start date: August 2016
Phase: N/A
Study type: Interventional

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA by ensuring that the iron needs of infants and young children are met without changing their traditional diet. In order to optimize iron absorption timing of MNP consumption might as well be important. This is because hepcidin, a key regulator of systemic iron balance, shows a circadian increase that may influence morning versus afternoon iron absorption from the MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit iron absorption from a second dose, consumed close in time to the first dose. To determine the difference between i) morning versus afternoon iron absorption and ii) consecutive versus alternate day iron absorption, investigators will enrol 20 infants from Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days and 1 alternate day. In both studies, fourteen days after the last test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. Hepcidin concentrations will be measured before the morning and afternoon meals (study 1) and after second consecutive meal (study 2). Knowing the effect of time on the expected iron absorption will inform decisions on the ideal timing of MNP to cover the infant's requirement for absorbed iron.

NCT ID: NCT02968368 Completed - Clinical trials for Renal Insufficiency, Chronic

Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

AEGIS-CKD
Start date: December 1, 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD