FORTE

Current guidelines for iron recovery in whole blood donors in The Netherlands include extended donation intervals for donors with low ferritin levels. Iron supplementation could serve as an alternative, shortening iron store recovery time. However, the effects of iron supplementation on donor health and behavior are largely unknown, and the optimal iron supplementation protocol in terms of frequency and dose has not yet been determined. With the FORTE study we will evaluate the impact of different iron supplementation protocols on iron status-related blood markers and donor health and behavior compared to placebo supplementation.

Whole blood donors with low ferritin levels were invited to participate in a randomized controlled trial. Participants followed a supplementation protocol including iron or placebo supplements with varying intake frequencies and iron dosages. Blood samples were taken to determine ferritin and hemoglobin levels and donors completed questionnaires to determine iron deficiency-related symptoms, lifestyle habits, and general health.  

The data collection for the FORTE study started in July 2021 and was finished in July 2023. In total about 2000 donors were included in the study. The results are expected to be available from the first quarter of 2024 and will serve as scientific evidence to guide the debate if, and if shown effective, how, iron supplementation could be implemented as a standard policy for whole blood donors with low ferritin levels. This is the first study to investigate the effect of iron supplementation on a multitude of outcomes, including measures of compliance, side effects, and iron deficiency related symptoms. 
Donor perceptions on iron supplementation are also being investigated.

Publications related to the FORTE trial are found here.