Paul Vaucher DiO MSc, Pierre-Louis Druais MD, Sophie Waldvogel MD, Bernard Favrat MD
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Background: The true benefit of iron supplementation
for nonanemic menstruating
women with fatigue is unknown. We studied
the effect of oral iron therapy on fatigue and
quality of life, as well as on hemoglobin, ferritin
and soluble transferrin receptor levels, in
nonanemic iron-deficient women with unexplained
Methods: We performed a multicentre, parallel,
randomized controlled, closed-label,
observer-blinded trial. We recruited from the
practices of 44 primary care physicians in
France from March to July 2006. We randomly
assigned 198 women aged 18–53 years
who complained of fatigue and who had a
ferritin level of less than 50 ug/L and hemoglobin
greater than 12.0 g/dL to receive
either oral ferrous sulfate (80 mg of elemental
iron daily; n = 102) or placebo (n = 96) for
12 weeks. The primary outcome was fatigue
as measured on the Current and Past Psychological
Scale. Biological markers were measured
at 6 and 12 weeks.
Results: The mean score on the Current and Past
Psychological scale for fatigue decreased by
47.7% in the iron group and by 28.8% in the
placebo group (–18.9%, 95%CI –34.5 to –3.2;
p = 0.02), but there were no significant effects
on quality of life (p = 0.2), depression (p = 0.97)
or anxiety (p = 0.5). Compared with placebo,
iron supplementation increased hemoglobin
(0.32 g/dL; p = 0.002) and ferritin (11.4 ìg/L; p <
0.001) and decreased soluble transferrin receptor
(–0.54 mg/L; p < 0.001) at 12 weeks.
Interpretation: Iron supplementation should
be considered for women with unexplained
fatigue who have ferritin levels below 50 ìg/L.
We suggest assessing the efficiency using
blood markers after six weeks of treatment.
Trial registration no. EudraCT 2006–000478–56.