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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT02276690 Completed - Anemia Clinical Trials

Hepcidine and Iron Deficiency in Critically Ill Patients

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

Anaemia is very frequent among critically ill patients, concerning more than 60 % of them at admission and more than 80% at intensive care unit discharge. Iron deficiency is also frequent at admission, with prevalence around 25 to 40%. During their stay in Intensive Care Unit, critically ill patients are exposed to repeated blood samples and to other blood losses (daily blood loss has been evaluated to be as high as 128 ml/day in median), this leads to direct iron loss. Prevalence of iron deficiency may thus be very important at Intensive Care Unit discharge. However, iron deficiency diagnosis is complicated in these patients, since inflammation induces an increase in plasma ferritin levels and a decrease in transferrin saturation, the two usual markers of iron deficiency. As a consequence, iron deficiency is usely under-diagnosed in these patients. Treatment of iron deficiency may be indicated to correct anaemia but also to improve patients fatigue and muscular weakness. The characterization of iron metabolism regulation by the hormone hepcidin opened new ways for the understanding and the follow-up of these complex clinical situations (combining inflammation and iron deficiency). Indeed, iron deficiency is associated with a decrease in hepcidin synthesis, while iron overload induces hepcidin synthesis. Furthermore, low hepcidin levels are required to mobilize iron from stores. Hepcidin has thus be proposed as a marker of iron deficiency in critically ill patients. To date, standard immunological methods of hepcidin quantitation are only proposed in the reasearch setting and could not be proposed in the clinical setting because it is too expensive. New approaches for hepcidin quantification, based on mass spectrometry are proposed and may be routinely implemented. We make the hypothesis that treating iron deficiency in critically ill anemic patients, diagnosed by hepcidin quantification, may improve the post-Intensive Care Unit rehabilitation, and may thus reduce post-Intensive Care Unit cost linked to hospital stay and anaemia treatment. The aim of this study is to evaluate the medical economic interest of a new diagnostic method for iron deficiency, based on a quantitative dosage of hepcidin by mass spectrometry in critically ill anaemic patients.

NCT ID: NCT02271997 Completed - Iron Deficiency Clinical Trials

Optimizing Iron Suppletion After Roux-en-Y Gastric Bypass

Ironsuppletion
Start date: December 4, 2014
Phase: Phase 4
Study type: Interventional

Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.

NCT ID: NCT02255942 Completed - Iron Deficiency Clinical Trials

The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate

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

Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.

NCT ID: NCT02245321 Completed - Iron Deficiency Clinical Trials

Strategies to Reduce Iron Deficiency

STRIDE
Start date: June 2011
Phase: N/A
Study type: Interventional

The prevalence of iron deficiency in blood donors has been demonstrated to be a direct consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is priority to implement programs to remediate iron deficiency issues associated with blood donations. To explore this issue, the study's aims to: 1. Determine whether regular blood donors provided with accurate information about their iron status and written recommended courses of action will take steps to prevent/mitigate iron deficiency on their own without being given iron supplements by the blood center; and 2. Determine if two different amounts of iron provided by the blood center will prevent/mitigate iron deficiency in regular blood donors. To conduct this randomized, placebo controlled study, participant donors will be assigned to one of two arms and followed for a 24 month period. Each subject will provide additional blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results. Under the two study arms, subjects are to be randomized into one of the following five blinded categories: - Receive a thank you letter after each blood donation. - Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. - Receive pills to take daily that contain no iron (a placebo or inert pill). - Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron). - Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).

NCT ID: NCT02242188 Recruiting - Iron Deficiency Clinical Trials

Supplementing Iron and Development in Breastfed Infants (SIDBI Study)

SIDBI
Start date: September 2015
Phase: Phase 4
Study type: Interventional

INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants beginning at 4 months of age. Uncertainty exists regarding the effects of iron supplementation during infancy on neurodevelopmental outcomes in the absence of anemia. AIM To establish whether psychomotor and mental development is influenced by early iron supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants. METHODS Healthy term newborns will be recruited shortly after birth. If predominantly breastfed (>50% daily feedings) and non-anemic at 4 months, they will be randomized to receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age. Participants will be assessed with use of Bayley Scales of Infant and Toddler Development (Bayley III) at 12, 24 and 36 months of age.

NCT ID: NCT02233764 Completed - Iron Deficiency Clinical Trials

Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India

Start date: May 8, 2017
Phase: N/A
Study type: Interventional

In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function in comparison to children receiving non-biofortified pearl millet.

NCT ID: NCT02232906 Completed - Iron Deficiency Clinical Trials

Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.

NCT ID: NCT02222805 Completed - Anemia Clinical Trials

Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment

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

The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth. The children will be followed with blood tests (hemoglobin and ferritin) at 8 and 12 months of age, and their development is evaluated by questionnaire (Ages & Stages Questionnaire ) at 12 months of age, and by testing (Bayley -III) at 18-24 months of age. By implementing the project in a country with a high proportion of anemia at one year of age (about 75%), we can reduce the number of children in the study and still achieve significant results. Iron deficiency is a global health problem and causes anemia and impaired neurodevelopment in children. Anemia is estimated by WHO to occur among 25% of all children before school age, and the corresponding figure in Europe is 3-9 %. By waiting 3 minutes to clamp the cord after birth, a large part of the child's blood volume remaining in the placenta is transfused over to the child's body. Research shows that the neonate's blood volume can increase by about 40% and this blood contains 3 to 4 months' supply of iron. In Sweden, we have shown that late clamping of the umbilical cord could reduce iron deficiency in children at four months of age by 90%. Globally, most countries practice early cord clamping and the child is deprived of the placental blood transfusion. The hypothesis of the study is that by delaying the clamping of the umbilical cord, anemia at 8 and 12 months will be reduced an this in turn will be beneficial for the childrens development. The project will be implemented at Paropakar Maternity and Women 's Hospital, Kathmandu. It hosts approximately 23,000 births annually.

NCT ID: NCT02221752 Completed - Clinical trials for Iron Deficiency Anemia

Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health

Start date: June 2009
Phase: N/A
Study type: Interventional

According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at the same time showed that the prevalence of IDA among pregnant and lactating mothers was 46.39% and 47.21% respectively. There was a significant difference between urban and rural areas. Women living in rural areas had higher chances of having IDA (p<0.01). WHO and UNICEF recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we don't know much about their influence on maternal and infant health and their clinical effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy and during early pregnancy. But for various reasons, not all expecting mothers take this advice. Besides, we don't have a national level technical standard of how to take nutrition supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or folic acid only can prevent perinatal complications, as well as their influences on infant and toddler health. The purpose of this study is to test whether taking iron/folic acid and folic acid only from early pregnancy until delivery will lower the chances of pregnancy complications, and to see how supplements affect gestation results. As well, it will evaluate a) whether taking iron supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron supplement can increase mother and fetus iron storage; and c) how mother's iron level affects newborn's iron level. We hope to understand nutrition conditions during pregnancy and investigate the relations between pregnancy diet and complications during pregnancy, weight gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking iron and folic acid during pregnancy on the health of infants and toddlers.

NCT ID: NCT02213653 Terminated - Clinical trials for Solid Cancer Metastatic Disease

Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Anemia in patients with cancer is a common problem associated with an impaired quality of life. Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased transfusion requirements. Absolute or functional iron deficiency is also common with about 30% of cancer patients with all histologies combined iron deficiency and anemia. Several studies have shown the benefits of the combination of intravenous iron to erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the investigators knowledge, has not been specifically performed on a population of patients with functional iron deficiency. In addition, in clinical practice, this association is not carried out in particular because there is no dosage or consensus sequence for the administration of iron associated with ESAs.