The effects of intravenous iron supplementation on fatigue and general health in non-anemic blood donors with iron deficiency: a randomized placebo-controlled superiority trial.
Study Goal
The researchers aimed to determine whether intravenous iron supplementation improves fatigue and general health in non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L).
Results Summary
Intravenous iron supplementation significantly increased ferritin and hemoglobin levels but had no effect on fatigue or general well-being compared to placebo. No group differences were observed for clinical and safety outcomes.
Population
Non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L).
Effective Dosage
Single intravenous dose of 800 mg iron-carboxymaltose.
Duration
6 to 8 weeks after intervention.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
intravenous iron supplementation | no change | self-rated mean fatigue scores | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) | 3.9 ± 1.8 in the iron supplementation group and 4.0 ± 2.2 in the placebo group | showed no group difference | #1 |
intravenous iron supplementation | no change | fatigue | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) with pre-specified subgroup analyses of gender, ferritin < 25 µg/L and fatigue ≥ 4 points | - | did not reveal any between-group differences | #2 |
intravenous iron supplementation | no change | fatigue | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) with exploratory analyses of lower ferritin cut-offs | - | did not reveal any between-group differences | #3 |
intravenous iron supplementation | increase | ferritin | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) | mean differences were 114.2 µg/L (95% CI 103.1-125.3) | significantly higher values | #4 |
intravenous iron supplementation | increase | hemoglobin | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) | mean differences were 5.7 g/L (95% CI 4.3-7.2) | significantly higher values | #5 |
intravenous iron supplementation | no change | different measures of general well-being | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) | - | No group differences were observed | #6 |
intravenous iron supplementation | no change | other clinical and safety outcomes | non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L) | - | No group differences were observed | #7 |
intravenous iron supplementation | increase | ferritin levels | repeat blood donors with low iron stores | - | resulted in increase | #8 |
intravenous iron supplementation | increase | hemoglobin levels | repeat blood donors with low iron stores | - | resulted in increase | #9 |
intravenous iron supplementation | no change | fatigue | repeat blood donors with low iron stores | - | had no effect | #10 |
intravenous iron supplementation | no change | general well-being | repeat blood donors with low iron stores | - | had no effect | #11 |
We investigated whether intravenous iron supplementation improves fatigue and general health in non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L). Of 1,487 potentially eligible participants, 203 were randomly assigned to a single intravenous dose of 800 mg iron-carboxymaltose and 202 to placebo; 393 participants completed the trial. At 6 to 8 weeks after intervention, self-rated mean fatigue scores (numeric rating scale from 1-10, primary outcome) were 3.9 ± 1.8 in the iron supplementation group and 4.0 ± 2.2 in the placebo group, showing no group difference (p = 0.819). Pre-specified subgroup analyses of gender, ferritin < 25 µg/L and fatigue ≥ 4 points, as well as exploratory analyses of lower ferritin cut-offs did not reveal any between-group differences. In terms of secondary outcomes, the mean differences were 114.2 µg/L for ferritin (95% CI 103.1-125.3) and 5.7 g/L for hemoglobin (95% CI 4.3-7.2) with significantly higher values in the iron supplementation group. No group differences were observed for different measures of general well-being and other clinical and safety outcomes. Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.