Post Gastrectomy Anemia Clinical Trial
Official title:
Intravenous Iron Isomaltoside 1000 (Monofer®) Compared With Oral Iron in the Treatment of Postgastrectomy Anemia: An Open-label Randomized Controlled Trial
Iron deficiency anemia is a common complication in patients who underwent gastrectomy and
leads to a deterioration in patient's quality of life. Therefore iron supplementation is one
of the important treatments in postgastrectomy patients.
Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients
has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron
supplementation has been emerged as another treatment option, but there are only a few
studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron
in patients underwent gastrectomy.
Therefore, this study aims to evaluate the iron supplementation method as intravenous
injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy
anemia.
Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and
hemoglobin level lower than 11 g/dL will be included in this trial. After the registration,
the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n =
179).
Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in
intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral
iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of
life score at baseline and weeks 12 period will be evaluated.
n/a