Evaluation Of A Single Dose Of Ferric Carboxymaltose In Fatigued, Iron-deficient Women--PREFER A Randomized, Placebo-controlled Study
Notes for this study:
||VAS 0-100. Mean + SD. Placebo: before 58.7 (16.0), after 63.6 (15.1). Iron: before 56.5 (16.1), after 66.6 (17.6).
|Number of Subjects
In a randomized, placebo-controlled, single-blind trial, 294 premenopausal women with iron deficiency but not anemia were given an intravenous dose of 1000 mg of iron from ferric carboxymaltose or saline and followed for 56 days. The iron dose ensured that participants in the iron group weren't iron-deficient or anemic.
There was a modest improvement in fatigue as assessed by the Piper Fatigue Scale score, and 65% of participants in the iron group saw a response as opposed to 53% in the placebo group. The improvement was a general one across the various behavioral, affective, sensory, and cognitive/mood symptoms.
There was a modestly greater rate of headaches, nasopharyngitis, pyrexia, and nausea in the iron group, which was generally mild or moderate.