Ferritin-guided iron supplementation in whole blood donors: optimal dosage, donor response, return and efficacy (FORTE)-a randomised controlled trial protocol.
Study Goal
The researchers aimed to evaluate the impact of different iron supplementation protocols (dosage and frequency) on ferritin and hemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms, and donor return compared to placebo.
Results Summary
The study assessed the effects of 30 mg and 60 mg iron supplements administered daily or on alternate days for 56 days, measuring ferritin, hemoglobin, gastrointestinal symptoms, and donor return. Results were not fully detailed in the abstract, but the study aimed to optimize effectiveness while minimizing side effects.
Population
Whole blood donors with ferritin levels ≤30 µg/L.
Effective Dosage
0 mg (placebo), 30 mg, or 60 mg, administered daily or on alternate days.
Duration
56 days.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Oral iron supplementation | decrease | iron store recovery time | whole blood donors | - | shorten | #1 |
Oral iron supplementation | increase | gastrointestinal complaints | whole blood donors | - | induce | #2 |
different iron supplementation protocols in terms of dosage and frequency | neutral | ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return | whole blood donors with ferritin levels ≤30 µg/L | - | evaluate the impact of | #3 |
different frequencies and dosages of administration of iron supplements | neutral | iron status and health effects | whole blood donors with low ferritin levels | - | provide a comprehensive overview of the effects of | #4 |
BACKGROUND: Frequent whole blood donors have an increased risk of developing iron deficiency. Iron deficiency can have detrimental health effects when left untreated. Donation intervals are commonly too short to replenish iron stores and extending these reduces donor availability. Oral iron supplementation is known to shorten iron store recovery time but may also induce gastrointestinal complaints. We aim to optimise the effectiveness of iron supplements while minimising the risks of side effects. Therefore, we will evaluate the impact of different iron supplementation protocols in terms of dosage and frequency on ferritin and haemoglobin levels, gastrointestinal side effects, iron deficiency-related symptoms and donor return compared with placebo supplementation. METHODS: Twelve hundred whole blood donors with ferritin levels ≤30 µg/L are included into a double-blind, randomised controlled trial. Participants are randomly allocated to one of six arms, administering capsules containing 0 mg, 30 mg or 60 mg of iron, either on alternate days or daily for 56 days. At baseline and 56, 122 and 182 days of follow-up, ferritin and haemoglobin levels are measured, and compliance, donor return, dietary iron intake, gastrointestinal, iron deficiency-related symptoms and general health are assessed by questionnaire. ETHICS AND DISSEMINATION: This study will provide a comprehensive overview of the effects of different frequencies and dosages of administration of iron supplements on iron status and health effects, thereby considering individual differences in treatment adherence and lifestyle. The outcome will provide scientific evidence to guide the debate if and how oral iron supplements may support the recovery of whole blood donors with low ferritin levels. TRIAL REGISTRATION NUMBER: NL8590; The Dutch trial registry.