An interventional study of Ferumoxytol and Ferrous sulfate in IDA in the Post-bariatric Surgical Patient, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
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Exclusion Criteria:
Ferumoxytol intravenous (IV) 1020 mg as - 2 vials of 510 mg (510 mg IV over 15 minutes) each given 2-7 days apart. Participants in this group will also receive oral vitamin C as a placebo.
Drug: Ferumoxytol · Other: Oral vitamin C
Ferrous sulfate 325 mg (oral) tabs morning and evening. Participants in this group will also receive intravenous normal saline as a placebo.
Drug: Ferrous sulfate · Other: Intravenous normal saline
treatment of iron deficiency anemia with IV iron.
treatment of iron deficiency anemia with oral iron
Oral vitamin C to be used as a placebo for participants receiving IV iron
Intravenous normal saline will be used as placebo for participants receiving oral iron
Resolution of anemia in oral vs. IV iron as assessed by Clinical Global Impression (CGI) - 2 score
The CGI-2 is a one-item questionnaire which asks how participants feel now compared to before receiving treatment. It has a scoring of 1 to 7 with 1 meaning much better and 7 meaning very much worse
Time frame: 6 weeks
Resolution of anemia in oral vs. IV iron as assessed by ferritin level
Participants will be assessed after six weeks to see if there is a resolution of anemia following the treatment with oral or IV iron. This will be determined by the ferritin level. Ferritin \> 20% will be the cutoff for resolution of anemia.
Time frame: 6 weeks
Resolution of anemia in oral vs. IV iron as assessed by TSAT
Participants will be assessed after six weeks to see if there is a resolution of anemia following the treatment with oral or IV iron. This will be determined by TSAT level. TSAT \> 19% will be the cutoff for resolution of anemia.
Time frame: 6 weeks
Time (weeks) to treatment response as assessed by CGI-2 score
The CGI-2 is a one-item questionnaire which asks how participants feel now compared to before receiving treatment. It has a scoring of 1 to 7 with 1 meaning much better and 7 meaning very much worse. This will be used in assessing the time in weeks when participant noticed a change after receiving treatment.
Time frame: 6 weeks
Time (weeks) to treatment response as assessed by ferritin level
Participants will be assessed after six weeks to identify what time (in weeks) ferritin level was \> 20% following the treatment with oral or IV iron
Time frame: 6 weeks
Time (weeks) to treatment response as assessed by TSAT
Participants will be assessed after six weeks to identify what time (in weeks) TSAT level was \> 19% following the treatment with oral or IV iron
Time frame: 6 weeks
Need for continued treatment as assessed by ferritin level
Participants will be assessed after a year to see if participants require continued treatment following the treatment with oral or IV iron. This will be determined by the ferritin level. Ferritin \> 20% will be the cutoff for no further need for treatment.
Time frame: 1 year
Need for continued treatment as assessed by TSAT
Participants will be assessed after a year to see if participants require continued treatment following the treatment with oral or IV iron. This will be determined by TSAT level. TSAT \> 19% will be the cutoff for no further need for treatment.
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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