Effect of iron supplementation on fatigue in nonanemic menstruating women with low ferritin: a randomized controlled trial.
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 fatigue.


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 (difference -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 μg/L; p<0.001) and decreased soluble transferrin receptor (-0.54 mg/L; p<0.001) at 12 weeks.


CONCLUSIONS
Iron supplementation should be considered for women with unexplained fatigue who have ferritin levels below 50 μg/L. We suggest assessing the efficiency using blood markers after six weeks of treatment. Trial registration no. EudraCT 2006-000478-56.
Department of Community Medicine and Primary Care, University of Geneva, Switzerland.
Paul
P
Vaucher
Pierre-Louis
PL
Druais
Sophie
S
Waldvogel
Bernard
B
Favrat
D000293:Adolescent; D000328:Adult; D019587:Dietary Supplements; D005221:Fatigue / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005293:Ferritins / Q000097:blood*; D005296:Ferrous Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D006454:Hemoglobins; D006801:Humans; D007501:Iron / Q000008:administration & dosage / Q000627:therapeutic use*; D008598:Menstruation; D008875:Middle Aged; D011788:Quality of Life; D016037:Single-Blind Method; D055815:Young Adult
D005296:Ferrous Compounds; D006454:Hemoglobins; C020748:ferrous sulfate; D005293:Ferritins; D007501:Iron