Effect Of Iron Supplementation On Fatigue In Nonanemic Menstruating Women With Low Ferritin: A Randomized Controlled Trial
Notes for this study:
||CAPPS anxiety. Mean + SD change. Placebo: −3.5 (9.1) Iron: −5.5 (9.0)
|Number of Subjects
||18-29, 30-44, 45-64
In a randomized, double-blind, placebo-controlled trial, 198 premenopausal women with low iron but not anemia were assigned to 80 mg of elemental iron from ferrous sulfate or placebo for 12 weeks.
Funding issues for this study:
Hemoglobin and ferritin were increased more in the iron group than the placebo group. The primary outcome was fatigue on the Current and Past Psychological Scale, and the iron group saw a modestly greater reduction than the placebo group, which was statistically significant, and higher for those with lower hemoglobin and lower for those with lower ferritin. Reduction in score on the Multidimensional Assessment of Fatigue Scale Index was also greater in the iron group, which was also significant compared with the placebo. There wasn't a statistically significant improvement in depression, anxiety, or quality of life in the iron group compared with the placebo group.
There was a somewhat higher rate of adverse events in the iron group (34.3%) as opposed to the placebo group (25%), which was statistically significant.
Funding: "The study was sponsored and funded by Pierre Fabre Médicament; however, the authors worked independently and were financed by their own academic institutions. Pierre Fabre Médicament, Boulogne, France, designed the study and was responsible for collecting and managing data. Pierre Fabre Médicament accorded total independence to Paul Vaucher, Bernard Favrat and Sophie Waldvogel in their analysis, interpretation of data, and preparation and approval of the manuscript. All authors had full access to all data (including intermediate reports, full databases, statistical reports and reports on adverse events) in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Authors from the universities of Lausanne and Geneva did not receive any financial or material favours from Pierre Fabre for their contributions and were entirely financed by their institutions. Statistical analysis was done by Paul Vaucher; no compensation or funding was received for conducting the analysis."
Competing interests: " Bernard Favrat, Paul Vaucher and Sophie Waldvogel have received funding from Robapharm and Pierre Fabre for a study of the effects of iron supplementation in blood donors. Bernard Favrat is a member of an iron deficiency meeting board sponsored by Vifor Pharma. He has given lectures to and provided expert testimony for Pierre Fabre Médicament and Vifor Pharma. He holds grant funding from Pierre Fabre Médicament and Vifor Pharma. Pierre-Louis Druais has received consulting fees from Pierre Fabre Médicament."