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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT01100905 Completed - Clinical trials for Iron Deficiency Anemia

An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers

Start date: n/a
Phase: N/A
Study type: Interventional

Military personnel face intense physical and cognitive demands. Diminished iron status affects physiologic responses to these challenges. Both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (BCT). Decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. The primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during BCT. This study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. Furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female Soldiers.

NCT ID: NCT01100879 Terminated - Clinical trials for Iron-Deficiency Anemia

Ferric Carboxymaltose for Treatment of Anaemia of Cancer in Subjects With Multiple Myeloma Receiving Chemotherapy

AOC-MM
Start date: March 2010
Phase: Phase 4
Study type: Interventional

Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of ferric carboxymaltose (FCM) in treatment of anaemia in subjects with multiple myeloma (MM) initiating chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion and randomised to receive intravenous infusions of FCM or standard care (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). Thereafter the visits are scheduled at Weeks 0, 2, 4, 6 and 8.

NCT ID: NCT01092377 Completed - Anemia Clinical Trials

The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children

FeFA
Start date: February 2010
Phase: N/A
Study type: Interventional

The aim of this study is to determine if providing iron and a mixture of DHA and EPA, alone and in combination, to children with iron deficiency and poor n-3 fatty acid intake will improve their cognitive performance, activity levels and immune system. Additionally, the effects on iron and fatty acid status, and gut microbiota, will be assessed.

NCT ID: NCT01088958 Completed - Clinical trials for Anemia, Iron-deficiency

Effectiveness of Selling Micronutrient Sprinkles in Rural Kenya

NICHE
Start date: January 2007
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the effectiveness of household-based distribution of evidence-based health products and to measure the health impact of these combined interventions on a population basis.

NCT ID: NCT01071759 Recruiting - Pregnancy Clinical Trials

Effects of Dietary Heme/Non-heme Iron and Helicobacter Pylori (Hp) Infection on Maternal Iron-deficiency Anemia and Fetal Growth Outcomes

Start date: February 2009
Phase: N/A
Study type: Observational

Iron deficiency is considered one of the main nutritional deficiency disorders despite the apparent availability of a high-quality diet even in developed countries, and Iron deficiency anemia (IDA) is the most common form of anemia in the world. IDA during pregnancy has been associated with adverse health consequences for both the mother and her developing fetus. Helicobacter pylori (Hp) may be the most common bacterial infection worldwide, infecting almost half of people in developed countries and 80% of people in developing countries. The available data on the prevalence of Hp infection in Taiwan population was 54.4%. We all know that infection with Hp is strongly associated with peptic ulcer and gastric cancer, but recent evidence suggests that Hp is associated with iron deficiency and anemia, although the mechanisms remain unclear. Till now, only few previous studies specifically have addressed a potential role of Hp infection on anemia or iron deficiency during pregnancy. Our previous Research showed, between the Hp infection (+) and Hp infection (-) gravidas, the associations between the Hp infection and iron deficiency were stronger, although not statistically significant. This might be due to that we needed more cases and evidences to prove the relationship between maternal Hp infection and serum iron, ferritin and hemoglobin levels, or we should further consider the interactions of the particular customs or diet preference of the Taiwanese gravidas. This longitudinal study will recruit 140 women from the antenatal care clinics of E-Da Hospital to examine the association between Hp infection and maternal IDA. The standardized interviews of mothers (anthropometric data, socioeconomic status, medical history, obstetric history, alcohol consumption during pregnancy, and history and duration of iron supplementation during pregnancy) will be conducted, Hp infection status will be determined by the urea breath test and IgG enzyme immunoassay, and the measurement of hemoglobin, iron, and ferritin levels will be obtained 5 times at various antepartum and postpartum points of time during pregnancy (routine prenatal visits of 1st, 2nd, and 3rd trimester, puerperium and 2 weeks after delivery). We hope that we could investigate the possible role of Hp infection in iron deficiency and iron-deficiency anemia during pregnancy in Taiwan, and that early detection and treatment of anemia may reduce the risk of blood transfusion and perinatal and maternal mortality.

NCT ID: NCT01067547 Completed - Clinical trials for Inflammatory Bowel Disease

A Trial of Iron Replacement in Patients With Iron Deficiency.

Start date: March 2010
Phase: Phase 4
Study type: Interventional

Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.

NCT ID: NCT01061307 Completed - Iron Deficiency Clinical Trials

An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand

Start date: September 2009
Phase: Phase 0
Study type: Interventional

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies. Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively. In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.

NCT ID: NCT01055431 Completed - Anemia Clinical Trials

A Functional Food for the Prevention of Iron-deficiency Anemia

Start date: October 2009
Phase: Phase 1
Study type: Interventional

It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and child. Studies show that low iron stores prior to conception and low iron intakes during pregnancy may both be contributing to this problem. Although dietary supplements may be one solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore, prescribed iron supplements may result in uncomfortable side-effects, including constipation (Wulff & Ekstrom, 2003). It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding that has been attributed to regular "Teff" consumption (Gies et al., 2003). Teff (Eragrostis tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a range of cereals). Research has shown that Teff is a rich source of iron that is easily absorbed by the body. Although it is believed that regular Teff consumption may prevent to onset of iron deficiency anemia there is no research to support this. Therefore, the aim of the present study is to es-tablish whether incorporating Teff into the daily diet may be one way to improve blood profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings will demonstrate whether Teff may be an alternative source of iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.

NCT ID: NCT01053442 Completed - Iron Deficiency Clinical Trials

Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate

SIA
Start date: January 2010
Phase: N/A
Study type: Interventional

Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA. The absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. As these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. This is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile. The use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, FePPi and NaFeEDTA given at fortification level with a meal.

NCT ID: NCT01052779 Completed - Anemia Clinical Trials

A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

FIRST
Start date: March 1, 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).