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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT04216030 Completed - Clinical trials for Iron Deficiency Anemia

IP Peru, Bioavailability of Iron From Potatoes

IPPERU
Start date: May 14, 2019
Phase: N/A
Study type: Interventional

To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Irish Potato (IP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron IP variety and a normal market level IP variety. The study is conducted in Peruvian women of reproductive age with marginal iron status.

NCT ID: NCT04206228 Active, not recruiting - Iron-deficiency Clinical Trials

Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

IIISAS
Start date: January 2, 2020
Phase: Phase 2
Study type: Interventional

Iron deficiency is a prevalent nutritional deficiency and a common cause of anemia. Although iron deficiency is traditionally linked to anemia, iron deficiency is prevalent even in the absence of anaemia and in itself limits function and survival. Iron deficiency is a common feature of various chronic diseases, and up to 50% of patients with heart failure have iron deficiency. Iron deficiency is more prevalent the more advanced the disease is and occurs more frequently in women. Iron deficiency comprises absolute iron deficiency (usually defined as ferritin < 100 ng/ml) as well as functional iron deficiency, in which iron supply is inadequate to meet the demand for the production of red blood cells and other cellular functions despite normal or abundant body iron stores. Iron deficiency is associated with poor exercise capacity, lethargy and reduced quality of life. Results from our studies have shown that iron deficiency is prevalent in patients with aortic stenosis. Some of the symptoms associated with aortic stenosis, such as fatigue, reduced exercise capacity, dyspnoea and cognitive dysfunction, have traditionally been thought to be caused by the haemodynamic derangements precipitated by the valvular stenosis. However, similar symptoms can be brought about by iron deficiency, and the investigators hypothesize that intravenous iron supplement will improve exercise capacity, muscle strength, cognition, health-related quality of life and myocardial function in patients with severe aortic stenosis and iron deficiency. This is a phase 2, double blind, randomised, placebo-controlled trial. Participants will be randomised in a 1:1 fashion to receive a single intravenous dose of iron isomaltoside (50 patients) or matching placebo (50 patients). The study is designed to show superiority with regard to the primary endpoint in patients assigned to active treatment versus patients allocated to the placebo arm. The main goal is to evaluate the effect of a single dose of intravenous iron isomaltoside on exercise capacity after transcatheter aortic valve implantation in patients with severe aortic stenosis and iron deficiency. For this study, the investigators have defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.

NCT ID: NCT04205266 Recruiting - Clinical trials for Anemia, Iron Deficiency

IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding

Start date: February 14, 2020
Phase: Phase 4
Study type: Interventional

This study investigates whether intravenous (IV) iron [Feraheme (ferumoxytol) injection)] is a better treatment than oral iron pills (ferrous sulfate) for correcting anemia in women who have heavy menstrual bleeding and anemia. Investigators will study whether women's blood counts respond better, respond more quickly, and if women prefer the IV treatment or the oral treatment. Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions. Investigators will then check whether and how quickly the anemia improves, and survey participants on how satisfied they were with the treatment.

NCT ID: NCT04198545 Active, not recruiting - Iron Overload Clinical Trials

Ethnic Differences in Iron Absorption (FeGenes)

FeGenes
Start date: August 1, 2019
Phase:
Study type: Observational

This study aims to; 1) investigate population differences in iron absorption between East Asians and Northern Europeans; 2) assess population differences in hormonal and biochemical determinants of Fe absorption between East Asians and Northern Europeans; and 3) to investigate genetic contributions to Fe absorption, Fe status and Fe regulatory hormones between East Asians and Northern Europeans.

NCT ID: NCT04194567 Completed - Iron-deficiency Clinical Trials

Effect of Polyphenols on Iron Absorption From Finger Millet

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

In India, one of the fast growing countries, 53% of all women have anaemia as per the National Family Health Survey. A recently published study on the burden of disease in India concluded that the burden of Iron deficiency anaemia (IDA) is 3 times higher than the average globally for other geographies at a similar level of development, and that women are disproportionately affected. Finger Millet (Eleusine coracana), more commonly known as Ragi, is a type of a millet crop grown in India, is considerably rich in minerals and its micronutrient density is higher than that of the world's major cereal grains: rice and wheat. Ragi also contains different antinutrients such as phytates and polyphenols, which have been known to have an inhibiting effect on the absorption of iron. On an average, white finger millet contains 0.04-0.09% polyphenols and brown varieties have 0.08-3.47%. The dark variety of ragi is the most widely consumed type. The white ragi is the lesser consumed type. However, the levels of polyphenols, which inhibit the absorption of iron, are ten times lower in the white ragi as compared to the dark ragi. Thus, it is important to evaluate the extent of inhibition of the polyphenols on the iron absorption. This information would be beneficial for policy making and promotion of cultivation of the type of ragi that could be most effective for the consumers

NCT ID: NCT04194255 Completed - Iron-deficiency Clinical Trials

The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements

Start date: July 20, 2020
Phase: N/A
Study type: Interventional

Iron deficiency (ID) remains the most common global nutrient deficiency, with young women at high risk. Iron supplements are first line treatment for ID but absorption is often low. Dietary components that could increase iron absorption would be valuable. Prebiotics are among the potential enhancers of non-heme iron absorption. Galacto-oligosaccharides (GOS), fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics. To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%). For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia. If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.

NCT ID: NCT04168346 Not yet recruiting - Gastric Cancer Clinical Trials

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

IRONSTOMACH
Start date: November 2019
Phase: Phase 4
Study type: Interventional

The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.

NCT ID: NCT04163406 Completed - Clinical trials for Anemia, Iron-deficiency

The Effect of Human Milk Oligosaccharides and Galacto-oligosaccharides on Iron Absorption in Kenyan Infants

FeHMOGOS
Start date: November 21, 2019
Phase: N/A
Study type: Interventional

Effective and safe strategies to deliver iron to infants and young children in Sub-Saharan Africa are urgently needed. One potential strategy to improve safety of iron fortification is to limit the total amount of unabsorbed iron entering the colon by lowering the daily iron dose but at the same time ensure efficacy by maximizing absorption from this lower dose. In Kenyan infants, the investigators have recently shown that consumption of 7.5 g of the prebiotic galacto-oligosaccharides (GOS) compared to no GOS consumption increased iron absorption from an iron containing micronutrient powder by ≈60%. It is uncertain whether a lower dose of GOS can also enhance iron absorption. Another question is whether HMOs, 'natural prebiotics' found in high concentration in human breast milk, can also increase iron absorption similar to GOS. Therefore, the aim of this study is to measure fractional iron absorption from a maize-based porridge fortified with A) iron as ferrous fumarate, B) iron as ferrous fumarate and GOS and C) iron ferrous fumarate and HMOs, using an established stable iron isotope technique in 55 infants aged 8-12 months living in Msambweni and surrounding rural communities, Kwale County of southern coastal Kenya. Assessing the effect of a low dose of GOS and of HMOs on iron absorption will provide valuable information towards the development of new, highly bioavailable iron formulations for African infants. As per the local standard of care, the participants who will be iron-deficient anemic at the end of the study will be treated with oral iron supplements. To evaluate the effects of iron supplementation on iron and anemia status and to estimate obligatory iron losses in the gastrointestinal tract, blood and fecal samples will be collected before, during and fourteen days after the beginning of the treatment with oral iron supplements. Data about the efficacy of current supplementation strategies in iron-deficient anemic children and obligatory iron losses would provide additional evidence for the optimization of iron supplementation regimens.

NCT ID: NCT04139265 Completed - Iron-deficiency Clinical Trials

Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency

CarenceMartial
Start date: June 6, 2019
Phase:
Study type: Observational

Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency

NCT ID: NCT04137354 Completed - Clinical trials for Anemia, Iron Deficiency

Iron and Vitamin A in School Children

IronVitA
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing. The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.