IDA in the Post-bariatric Surgical Patient Clinical Trial
Official title:
A Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient
The aim of the study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of iron deficiency anemia (IDA) in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.
Rationale for study: The preponderance of published evidence reports superior efficacy and
decreased toxicity of intravenous iron compared to oral iron in correcting anemia and iron
parameters in published trials of bariatric surgery patients. Intravenous, and not oral, iron
ensures adequate delivery and avoids gastrointestinal toxicities, which may be especially
burdensome in these patients who require optimal levels of energy to maintain prudent
exercise programs recommended by patients' bariatric practitioners. Uncontradicted published
evidence reports safety and efficacy of complete replacement doses of intravenous iron
administered in one or two doses of either low molecular weight iron dextran, ferumoxytol,
ferric carboxymaltose or iron isomaltoside. A common feature of all studies extant is the
lack of reported serious adverse events. Even in patients with minimally invasive procedures
such as gastric banding or stapling in whom oral iron may be tolerated, given the often
present multiple gastrointestinal perturbations, intravenous iron may simplify care.
Drugs used: The investigators propose to use and FDA approved IV iron preparation -
ferumoxytol, administered as two doses (over a interval of 2 to 7 days), each 510 mg over
fifteen minutes based on published prospective safety and efficacy data and compare the
effectiveness of the treatment to the American Metabolic and Bariatric Associations
recommended treatment for iron deficiency anemia in the post-operative bariatric patients of
oral iron ferrous sulphate 325 mg twice daily for 6 weeks.
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