CLINICAL TRIALS PROFILE FOR IRON SUCROSE
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505(b)(2) Clinical Trials for Iron Sucrose
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00262145 ↗ | Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption | Completed | NatureGen | Phase 1 | 2005-10-01 | Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies. |
| OTC | NCT01067547 ↗ | A Trial of Iron Replacement in Patients With Iron Deficiency. | Completed | Richard Fedorak | Phase 4 | 2010-03-01 | Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Iron Sucrose
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00111956 ↗ | Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome | Completed | Massachusetts General Hospital | Phase 2/Phase 3 | 2004-04-01 | Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome. |
| NCT00111956 ↗ | Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2/Phase 3 | 2004-04-01 | Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome. |
| NCT00125996 ↗ | Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure | Unknown status | 4th Military Hospital | Phase 1/Phase 2 | 2004-07-01 | This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF. |
| NCT00125996 ↗ | Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure | Unknown status | 4th Military Hospital, Poland | Phase 1/Phase 2 | 2004-07-01 | This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF. |
| NCT00125996 ↗ | Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure | Unknown status | Wexham Park Hospital | Phase 1/Phase 2 | 2004-07-01 | This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF. |
| NCT00125996 ↗ | Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure | Unknown status | National Heart and Lung Institute | Phase 1/Phase 2 | 2004-07-01 | This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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