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Anemia, Iron Deficiency clinical trials

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NCT ID: NCT02694978 Completed - Clinical trials for Iron Deficiency Anemia

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

Start date: February 29, 2016
Phase: Phase 3
Study type: Interventional

To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).

NCT ID: NCT02685501 Recruiting - Clinical trials for Iron Deficiency Anemia

Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers and Effect on Activity

Start date: January 2016
Phase: N/A
Study type: Observational

As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers compared to non-combat women soldiers. Using cohorts from the same environment will enable the investigators to better study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such as nutrition. The study does not include any intervention.

NCT ID: NCT02683369 Completed - Clinical trials for Non-anemic Iron Deficiency

Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women

Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.

NCT ID: NCT02680756 Completed - Crohn's Disease Clinical Trials

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

NCT ID: NCT02666417 Completed - Clinical trials for Anemia, Iron-Deficiency

Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)

FeGOS
Start date: January 2016
Phase: N/A
Study type: Interventional

Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia (IDA), which adversely affects their growth and cognitive development. In-home iron fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Thus, there is an urgent need to find safer formulations of iron fortification for African infants. The investigators recently finished a randomized, double blind controlled intervention trial in Kenya where the investigators tested whether the addition of galacto-oligosaccharides (GOS) in a MNP containing 5 mg of iron protects against the adverse effects of the iron on the infant gut microbiome and gut inflammation (ClincalTrails.gov Identifier: NCT02118402). Prebiotics are also potential enhancers of colonic iron absorption. Therefore, to complement the intervention study, the present study will compare iron absorption from the combination of sodium iron EDTA (NaFeEDTA) and ferrous fumarate (FeFum) with and without prior consumption GOS or 3 weeks. The investigators will enroll 80 Kenyan infants from Kwale County, aged 6-14 months of whom 40 infants will consume maize porridge blended with MNP containing iron and 40 infants will receive a porridge mixed with MNP containing iron+GOS. After 3 weeks of MNP consumption, two test meals will be fed on two consecutive mornings, and will consist of maize porridge containing isotopically labeled FeFum and NaFeEDTA or isotopically labeled ferrous sulfate (FeSO₄), respectively. Fourteen days after the second test meal administration, a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and inflammation status parameter will be determined at baseline and endpoint. A stool sample will be collected at baseline and on the first test meal day. The gut microbiome, fecal pH and fecal SCFAs profile will be analyzed. Knowing the expected iron absorption from the iron and GOS containing MNP will inform decisions on type of iron compound and dosing regimens for MNPs to allow the lowest iron dose to be used but still cover the infant requirement for absorbed iron.

NCT ID: NCT02654197 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children

Start date: June 2016
Phase: N/A
Study type: Observational

The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years.

NCT ID: NCT02642562 Completed - Clinical trials for Chronic Heart Failure

Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN

IRONMAN
Start date: August 2016
Phase: Phase 4
Study type: Interventional

This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.

NCT ID: NCT02631668 Completed - Clinical trials for Anemia, Iron-Deficiency

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

Start date: January 1, 2016
Phase: Phase 4
Study type: Interventional

IDA patients ofen receive ferrous succinate treatment to speed up the recovery of anemia, the doctor will prescribe ferrous succinate with or without vitamin C according to their own preferences. In theory, only the divalent iron can be absorbed in duodenum and upper jejunum, vitamin C can oxidize ferric iron into divalent iron and maintains a certain degree of acidity in the intestine, and then promotes the absorption of iron. In current clinical practice, it's lack of randomized controlled trial(RCT) about the efficacy and safety of vitamin C for iron supplementation in patients with IDA. In this study, the efficacy and safety of vitamin C for iron supplementation in adult IDA patients are explored by RCT. The dosage regimens of ferrous succinate with or without vitamin C are randomly assigned to patients who meet the inclusion criteria, and these patients are followed up every two weeks. On the one hand, whether the addition of vitamin C can accelerate the recovery of anemia is evaluated, on the other hand, whether the addition of vitamin C can increase the incidence of gastrointestinal tract discomfort is aslo appraised , the discomfort include vomiting, nausea, abdominal pain, diarrhea and constipation. We hypothesis that vitamin C can increase the absorption of iron and accelerate the recovery of anemia, it also increases incidence of gastrointestinal adverse events because of increased iron absorption at the same time.

NCT ID: NCT02620137 Completed - Clinical trials for Iron Deficiency Anemia

Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

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

A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.

NCT ID: NCT02619006 Terminated - Child Development Clinical Trials

Infant Brain Study Follow-Up at 3 and 4 Years of Age

Start date: November 2015
Phase:
Study type: Observational

When immediate clamping of the umbilical cord (ICC) occurs at birth, 20 to 30% of the fetal-placental blood volume is left behind in the placenta. Preliminary results from our current study comparing effects of ICC versus placental transfusion from delayed cord clamping (DCC) show that infants who have DCC have higher ferritin levels at 4 months of age and more myelin in important regions of the brain. Our objective for this follow-up study is to see if the effects of placental transfusion persist to three and four years of age. The investigators plan to enroll only children who participated in the previous trial (Infant Brain Study/NCT01620008) at birth for assessments at three and four years of age. Assessments include MRIs and neurodevelopmental testing to examine cognitive, motor, visual, and behavioral outcomes. The proposed research addresses two central questions regarding the potential benefits of DCC on brain myelin development in children who were born healthy at term: 1. Does DCC result in increased brain myelin deposition at three and four years of age? and 2) Are DCC, iron stores, and brain myelin content in infancy associated with improved cognitive, motor, and socio-behavioral outcomes at three and four years of age?