Previously submitted to: JMIR Research Protocols (no longer under consideration since Jul 02, 2026)
Date Submitted: Dec 31, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
BLOODSAFE Iron and Nutritional Counselling Strategy (BLIS): Protocol for a Randomized Controlled Trial to Enhance Blood Availability and Safety in Ghana
ABSTRACT
Background:
In Ghana, anemia-related deferrals significantly reduce the pool of eligible blood donors, weakening the national blood supply. To address this challenge, the BLOODSAFE Iron and Nutritional Counselling Strategy (BLIS) trial evaluates the effectiveness and safety of daily low-dose iron supplementation (65 mg elemental iron as ferrous sulfate) combined with nutritional counselling.
Methods:
This study is a randomized controlled trial embedded within a Type 1 pragmatic effectiveness-implementation hybrid design. It compares the intervention to standard care (nutritional counselling only) among prospective blood donors who were deferred due to low hemoglobin levels. With a target of 264 participants per group, the trial is powered at 80% to detect an odds ratio of 2.6, assuming 2.5 donation events per week over a 2-year period. The primary outcome is successful blood donation within one year of deferral, with secondary outcomes including the frequency of return donation attempts. Safety, adherence, and acceptability will be monitored through monthly follow-ups. Discussion: This trial aims to generate rigorous evidence to support scalable strategies that promote re-entry of deferred donors and ensure a safe and sufficient blood supply in Ghana, with broader relevance to other low- and middle-income countries facing similar challenges in blood donation systems.
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