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Iron Deficiency Anemia clinical trials

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NCT ID: NCT01282788 Completed - Malnutrition Clinical Trials

Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo

CAT02
Start date: January 2011
Phase: N/A
Study type: Interventional

Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micro-nutrients. Although supplementation with selected micro-nutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF and demonstrated maternal and infant acceptability. This study will investigate the efficacy in prevention of stunting of growth resulting from inadequate complementary foods. A sub-study will evaluate the biologic effects of the caterpillar cereal to determine whether caterpillar cereal prevents iron deficiency anemia, reduces the incidence of neurodevelopmental impairment or infectious diseases.

NCT ID: NCT01264679 Terminated - Clinical trials for Iron Deficiency Anemia

A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Start date: December 27, 2011
Phase: Phase 3
Study type: Interventional

Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.

NCT ID: NCT01245777 Completed - Clinical trials for Iron Deficiency Anemia

Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy

Start date: October 2009
Phase: Phase 4
Study type: Interventional

In pregnancy Restless Legs Syndrome(RLS) is more common than in the general population. During pregnancy iron tablets are the only available safe medication but their efficacy is rather poor. It is the aim of this study to examine the efficacy, practicability and safety of the drug Ferinject® containing the active agent Ferric carboxymaltose for the therapy of Restless Legs Syndrome(RLS) during pregnancy in the case of iron deficiency or anaemia. 20 women with RLS and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses. Repeated blood tests, pre-and post-therapy actigraphy as well as repeated answering of questionnaires concerning Restless Legs Syndrome(RLS)-symptoms and sleep quality will show the effect of iv-Iron supplementation on Restless Legs Syndrome(RLS)-symptoms during pregnancy. - Trial with medicinal product

NCT ID: NCT01224535 Completed - Anemia Clinical Trials

Improving Iron Status of Children: Potential of Amaranth

Start date: October 2010
Phase: N/A
Study type: Interventional

Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification. Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya. Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study. Study design: The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks. Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups. Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories. Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration <12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of >8.3mg/L. Infection will be assessed by raised CRP (>10mg/L) as an indicator of acute inflammation and presence of malaria.

NCT ID: NCT01221844 Completed - Pregnancy Clinical Trials

Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies

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

The purpose of this study is to determine whether bovine lactoferrin is effective in preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia affected women during pregnancy. The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized by Grunenthal, as Lattoglobina® (capsules with 100 mg of bLf), to prevent and cure iron deficiency and iron deficiency anemia in pregnant women.

NCT ID: NCT01166451 Completed - Clinical trials for Iron Deficiency Anemia

The Anemia Control Program: High or Low Iron Supplementation

Start date: September 1991
Phase: N/A
Study type: Interventional

The purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron status in infancy and on development longitudinally.

NCT ID: NCT01155388 Terminated - Clinical trials for Iron Deficiency Anemia

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

NCT ID: NCT01155375 Terminated - Clinical trials for Iron Deficiency Anemia

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

NCT ID: NCT01151592 Withdrawn - Clinical trials for Iron Deficiency Anemia

Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)

ASSURED
Start date: n/a
Phase: Phase 4
Study type: Interventional

The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).

NCT ID: NCT01148745 Completed - Clinical trials for Iron Deficiency Anemia

Iron Indices and Intravenous Ferumoxytol: Time to Steady State

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

The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.