Ferritin-guided iron supplementation as an alternative or complement to prolonged blood donation intervals (FORTE): a double-blind, randomised, controlled trial
Abstract
BACKGROUND: Regular blood donation is associated with an increased risk of iron deficiency and anaemia. Oral iron supplementation is known to shorten post-donation iron recovery time and could serve as an alternative to extended donation intervals. We aimed to evaluate the effect of different iron supplementation protocols on ferritin and haemoglobin levels, gastrointestinal side-effects, iron deficiency-related symptoms, and donor return compared with placebo supplementation.
METHODS: In this double-blind, randomised, placebo-controlled trial conducted at seven of Sanquin's blood donation centres in The Netherlands, donors aged 18-80 years with ferritin levels equal to or less than 30 μg/L were randomly allocated to one of six study groups, using block randomisation in equal numbers by sex and age. Donors were instructed to adhere to a ferrous bisglycinate supplementation protocol for 56 days, taking capsules containing 0 mg (placebo), 30 mg, or 60 mg of elemental iron, either daily or on alternate days. The primary outcomes were presence of iron deficiency (<15 μg/L), low ferritin (15-30 μg/L), and low haemoglobin (≤135 g/L for male donors and ≤125 g/L for female donors) at 56 days' follow-up. Analyses were conducted using an intention-to-treat approach. This trial is registered in the Dutch trial registry (NL7328.018.20) and is complete.
FINDINGS: Between Aug 1, 2021, and Jan 15, 2023, 830 donors (464 [56%] female donors and 366 [44%] male donors; 789 [95%] of Dutch…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 119 participants or records.
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