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Iron Deficiency clinical trials

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NCT ID: NCT01483768 Completed - Obesity Clinical Trials

Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients

FORBES
Start date: September 25, 2012
Phase: N/A
Study type: Interventional

Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal iron absorption of morbid obese subjects. Control of intestinal absorption of iron is mediated by hepcidin, which is expressed in adipose tissue and that its expression is increased in morbidly obese subjects. The working hypothesis is that this increase could explain the high prevalence of systemic iron depletion observed in obese patients. Main objective: Assess the impact of the decrease in fat mass induced by surgery in obese patients on the intestinal absorption of iron (evaluated by measuring the expression of iron transporters in the duodenum)

NCT ID: NCT01453608 Completed - Clinical trials for Chronic Heart Failure

A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

CONFIRM-HF
Start date: October 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.

NCT ID: NCT01447628 Completed - Clinical trials for Pulmonary Arterial Hypertension

IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients

Start date: March 29, 2011
Phase: Phase 2
Study type: Interventional

This study will establish whether intravenous iron replacement has clinical benefit in idiopathic pulmonary arterial hypertension. A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics, exercise capacity and quality of life and is well-tolerated. IV iron formulation used in Europe - Ferinject IV iron formulation used in China - CosmoFer

NCT ID: NCT01444261 Completed - Anemia Clinical Trials

Prevention of Iron Deficiency in Breastfed Infants

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

With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

NCT ID: NCT01443832 Completed - Iron Deficiency Clinical Trials

Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study

Start date: September 2010
Phase: Phase 0
Study type: Observational

The study sought to investigate the effect of lowering phytic acid in fonio porridge with phytase activity naturally occurring in wheat flour on iron absorption using labelled stable isotopes of iron. The study population is represented by 16 apparently healthy young Beninese women aged 18-30 years recruited based on their willingness to participate and according to inclusion criteria. Test meals consisted of fonio porridges fortified with isotopically labelled [57Fe] or [58Fe] ferrous sulfate with and without wheat flour. Meals were administered to fasting subjects on two consecutive days using a randomised crossover design: half the subjects received the test meal on the first day and the control on the second day and vice versa. Venous blood sample were collected (day 1 and day 14) for iron status and iron absorption measurement. Iron absorption measurement is based on erythrocyte incorporation of iron stable isotope labels 14 days after intake of the labelled test meals and calculated based on isotope-dilution.

NCT ID: NCT01412723 Completed - Iron Deficiency Clinical Trials

Ferrous Sulfate Versus Iron Amino Acid Chelate

Start date: October 2011
Phase: Phase 3
Study type: Interventional

Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide. Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate. It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.

NCT ID: NCT01404533 Completed - Iron Deficiency Clinical Trials

Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women

NTBIwomen
Start date: November 2009
Phase: N/A
Study type: Interventional

The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (~0.1 mg Fe/kg) — like that used in home fortification — with the standard rice meal.

NCT ID: NCT01394562 Completed - Clinical trials for Chronic Heart Failure

Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

EFFECT-HF
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.

NCT ID: NCT01321099 Completed - Anemia Clinical Trials

Iron Absorption From Complementary Food Fortificants (CFFs) and Acceptability of CFFs by Beninese Children

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

Iron deficiency (ID) is still a main public health problem in sub-Saharan Africa. Iron deficient children have an increased risk for anemia which is associated with adverse infant development that might be partly irreversible. In sub-Saharan Africa, the etiology of ID in children is multifactoral; but the major causes are low iron dietary bioavailability and intake from monotonous cereal-based complementary foods. Children < 5 years old can benefit from iron-fortified complementary foods; however, these fortified complementary foods are often not adapted to the requirements of children in specific setting. The investigators developed a complementary food fortificant (CFF) which is added to local porridge and is deemed to meet the nutrient intake requirement for iron in children 1-3 years of age. The CFF is lipid-based and can therefore, if regularly used, increase the daily energy intake of children which is often too low in developing countries with cereal-based diets. The iron absorption from the mixture of CFF and porridge has to be optimized because it contains quite a high amount of phytate, a well-known inhibitor of iron absorption. To optimize iron absorption the investigators are planning three iron absorption studies using different compounds of iron (FeSO4 + NaFeEDTA), additional vitamin C and phytase, which is able to degrade phytate. In the first study, iron absorption will be determined from a mixture of CFF and porridge fortified with 1) 6 mg FeSO4 and 2) 6 mg FeSO4 plus additional vitamin C. In the second study, the test meals will be fortified with 1) 6 mg FeSO4 and 2) a mixture of 3 mg FeSO4 + 3 mg NaFeEDTA. In the third study, test meals will be fortified with 1) 6 mg FeSO4, 2) 6 mg FeSO4 plus phytase, and 3) 6 mg FeSO4 plus additional vitamin C and phytase. Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable isotope technique). Sixty apparently healthy Beninese children 12-36 months of age with a body weight > 8.3 kg will be included in the study. Additionally, the investigators will test acceptability of CFFs based on different composition formulas by interviewing the parents/legal guardians of the children after feeding the CFF for a defined period. The results of these studies will provide important insights to optimize the iron absorption of young children from a CFF mixed with local traditional porridge in developing countries. Furthermore the studies will provide information on the acceptability of CFFs in such a setting.

NCT ID: NCT01245296 Completed - Iron Deficiency Clinical Trials

Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

Start date: April 2008
Phase: N/A
Study type: Interventional

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight. The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants. The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.