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Iron Deficiency clinical trials

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NCT ID: NCT01895231 Completed - Iron-deficiency Clinical Trials

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

NCT ID: NCT01874496 Completed - Iron Deficiency Clinical Trials

Iron Absorption From GDS Capsules

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

Slow release iron capsules have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.

NCT ID: NCT01847352 Completed - Clinical trials for Pulmonary Arterial Hypertension

Iron Status and Hypoxic Pulmonary Vascular Responses

Start date: February 2013
Phase: N/A
Study type: Interventional

On exposure to hypoxia (low oxygen) the normal response is for pulmonary arterial systolic blood pressure (PASP, blood pressure through the lungs) to increase. We have previously shown that raising iron by giving an infusion of iron into a vein reduces this pressure rise and that lowering iron by giving a drug that binds iron, magnifies this response. This is potentially a clinically important observation since iron-deficient people may be at increased risk of pulmonary hypertension if exposed transiently or permanently to hypoxia due to lung disease or residence at high altitude; furthermore if this were true then intravenous iron could be an important treatment in this patient group in the event of hypoxic exposure. The observed effects of iron on PASP are likely to be because iron levels affect oxygen sensing. Low iron levels make the body behave as if exposed to low oxygen by inhibiting the breakdown of the family of oxygen-sensing transcription factors, 'hypoxia inducible factor' or HIF. This includes one of the body's normal responses to low oxygen levels - raising blood pressure through the lungs. This study will answer the question (1) do iron-deficient volunteers have a greater rise in PASP with hypoxia than those who are iron-replete, and (2) does giving intravenous iron cause a greater reduction in the rise in PASP in those who are iron-deficient than iron-replete? The purpose of this study is not to test the safety or clinical efficacy of iron which is already known.

NCT ID: NCT01844349 Completed - Metabolic Syndrome Clinical Trials

Nutritional Transition in the Maghreb and Prevention of Obesity and Non-communicable Diseases

Obe-Maghreb
Start date: March 2009
Phase: N/A
Study type: Observational

Problematic and state of the art Obesity and its associated non communicable diseases (NCDs) are rising rapidly in middle income countries, such as those in the Maghreb (North Africa). This progression is related to the context of a nutrition transition (changing food and physical activity environment) and profound changes in technological advances and in society. These societies and their health systems are insufficiently prepared for this evolution, which has enormous health and socioeconomic consequences. In the context of limited resources, the priority has been given on an international level to prevention. But several problems arise: - these countries are still confronted by undernutrition in terms of micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level and also individual level. Known as the 'double burden', this coexistence is relatively new and has been rarely documented until recently. Educational measures could be ineffective in a society where cultural norms do not recognise obesity and where changes in lifestyle are possibly not seen as acceptable. As well as information about citizen's knowledge of risk factors, data on their perceptions and attitudes are indispensable. Policies that involve changing the 'obesogenic' environment that individuals occupy is a priority. Objectives of the project Overall aim: to contribute to the development of preventive strategies for obesity and chronic NCDs in the context of a nutrition transition. Specific objectives: characterise the nature and size of the double burden (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of biological and behavioural risk factors; characterise the psycho-sociocultural determinants of behaviour.

NCT ID: NCT01787526 Completed - Iron Deficiency Clinical Trials

Intravenous High Dose Iron in Blood Donors

IronWoMan
Start date: June 2014
Phase: Phase 3
Study type: Interventional

2-3% of the population participates in blood donation programmes. Traditionally, safety issues in transfusion medicine have been concentrating on product and recipient safety. Extensive efforts including strict donor inclusion criteria and testing for important transmissible infections have substantially improved product quality. One of the most common risks of blood donation is iatrogenic iron deficiency. It may affect up to 30% of regular blood donors because each whole blood donation causes a loss of 200 to 250 mg of iron. Although this has been known for at least 50 years, iron deficiency is not routinely assessed or treated in this population. Contributing factors include donation frequency, lower weight and female gender. Women have lower iron reserves and in premenopausal women, the daily required amount of iron is higher than in men. Besides anemia, iron deficiency may lead to fatigue and impaired cognitive and physical performance. Oral iron substitution is often associated with significant gastrointestinal side effects leading to poor compliance. Today, intravenous (iv.) iron preparations are well tolerated and allow the application of a large dose of 1000mg in one visit. Our hypothesis is that in blood donors with iron deficiency intravenous iron is feasible and preferable to oral iron because of its high efficacy and optimal compliance with a similar safety profile that has been extensively studied in other populations than blood donors.

NCT ID: NCT01785407 Completed - Anemia Clinical Trials

Using Stable Iron Isotopic Techniques and Serum Hepcidin Profiles to Optimize Iron Supplementation

Start date: February 2013
Phase: N/A
Study type: Interventional

Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose but the duration of the increase is uncertain: it may be in the range of 24 to 96 hr. Also, there are few data on how the increase in SHep determines the absorption of further doses of oral iron. Is there a threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding of this relationship would be valuable to design more effective and safer OIS regimens. Objectives: 1) Determine the duration and magnitude of the Fe induced Hepcidin rise form a single iron dose while determining its bioavailability and 2) Compare the bioavailability of a single dose to iron supplements consumed one after the other (two dosages).

NCT ID: NCT01754701 Completed - Malaria Clinical Trials

Acute vs. Delayed Iron: Effect on Red Cell Iron Incorporation in Severe Malaria

Start date: June 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether iron therapy given to iron-deficient Ugandan children with moderate-to-severe anemia and clinical malaria is better absorbed and incorporated into red blood cells if it is given concurrently with antimalarial treatment on Day 0 (immediate group) or 4 weeks after antimalarial treatment on Day 28 (delayed group). Use of iron stable isotopes 57Fe and 58Fe will permit measurement of red blood cell iron incorporation on Day 0 and Day 28 in all children. The investigators hypothesize that red cell iron incorporation at the time of initial supplement administration will be greater in children receiving delayed vs. immediate iron (Aim 1), and children in the delayed group will also have greater hematological recovery on Day 56 than children in the immediate group (Aim 2).

NCT ID: NCT01739907 Completed - Iron Deficiency Clinical Trials

Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women

Start date: January 2012
Phase: N/A
Study type: Interventional

Iron deficiency and vitamin D deficiencies are common in menstruating women. The present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin D3 in iron deficient women on: - Iron metabolism - Biomarkers of bone remodelling - Cardiovascular risk indexes

NCT ID: NCT01736397 Completed - Clinical trials for Iron Deficiency Anemia

Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

NCT ID: NCT01700426 Completed - Clinical trials for Iron Deficiency Anemia

Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The study addresses treatment of iron deficiency, the most common nutritional deficiency that infants and young children encounter. With the knowledge that iron deficiency may irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are offering free screening blood draws at Children's Hospital Colorado to older babies and toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15 micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be invited to continue in the intervention portion of the study, where they will receive iron supplements as well as vitamin E (or placebo) for an eight week treatment period. The rationale for the study is to test whether addition of Vitamin E, an antioxidant and anti-inflammatory agent, improves the treatment response to supplemental iron.