Effect of iron supplementation on fatigue in nonanemic menstruating women with low ferritin: a randomized controlled trial.
Study Goal
The researchers aimed to determine whether oral iron supplementation improves fatigue and quality of life in nonanemic, iron-deficient women with unexplained fatigue.
Results Summary
Iron supplementation significantly reduced fatigue scores compared to placebo (47.7% vs. 28.8%) and improved hemoglobin, ferritin, and soluble transferrin receptor levels, but had no significant effect on quality of life, depression, or anxiety.
Population
Nonanemic menstruating women aged 18-53 with ferritin <50 μg/L and hemoglobin >12.0 g/dL complaining of fatigue.
Effective Dosage
80 mg elemental iron (as ferrous sulfate) daily.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
oral ferrous sulfate (80 mg of elemental iron daily) | decrease | fatigue as measured on the Current and Past Psychological Scale | nonanemic iron-deficient women with unexplained fatigue | 47.7% | decreased | #1 |
placebo | decrease | fatigue as measured on the Current and Past Psychological Scale | nonanemic iron-deficient women with unexplained fatigue | 28.8% | decreased | #2 |
oral ferrous sulfate (80 mg of elemental iron daily) | no change | quality of life | nonanemic iron-deficient women with unexplained fatigue | no significant change | showed no significant effects | #3 |
oral ferrous sulfate (80 mg of elemental iron daily) | no change | depression | nonanemic iron-deficient women with unexplained fatigue | no significant change | showed no significant effects | #4 |
oral ferrous sulfate (80 mg of elemental iron daily) | no change | anxiety | nonanemic iron-deficient women with unexplained fatigue | no significant change | showed no significant effects | #5 |
iron supplementation | increase | hemoglobin | nonanemic iron-deficient women with unexplained fatigue | 0.32 g/dL | increased | #6 |
iron supplementation | increase | ferritin | nonanemic iron-deficient women with unexplained fatigue | 11.4 μg/L | increased | #7 |
iron supplementation | decrease | soluble transferrin receptor | nonanemic iron-deficient women with unexplained fatigue | -0.54 mg/L | decreased | #8 |
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. INTERPRETATION: 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.