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ID
Source
Brief title
Health condition
Non-anaemic iron deficiency
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the effects of four different iron supplementation protocols on ferritin and Hb levels and donor health, to placebo in donors with low ferritin levels.
Secondary outcome
The secondary outcome includes the difference in effects between different iron supplementation protocols
Background summary
Rationale: Regular whole blood donors are at risk of developing iron deficiency due to the haemoglobin (Hb) -bound iron loss. Because plasma Hb levels do not accurately correspond with a donor's true iron status, Sanquin Blood Bank introduced ferritin measurements in whole blood donors as an indicator for iron depletion. Donation intervals are extended to 6 or 12 months for donors with ferritin levels of ≥15 and ≤30 μg/L or <15 μg/L, respectively. This policy lowers donor availability and may therefore cause a decrease in donations made over time, leading to an inadequate blood supply. Iron supplementation after blood donation has been shown to effectively enhance the recovery of Hb and ferritin levels, particularly in donors with low ferritin. Iron supplementation could serve as an alternative to the extended donation intervals. However, for the implementation of iron supplementation, more insights are needed regarding the optimal supplementation protocol, effects on donation-related symptoms and health, and (non-)donors’ and blood bank personnel’s knowledge and perception regarding iron deficiency and supplementation.
Objective: The primary objective is to investigate effects of iron supplementation on markers of body iron status, donor health including side effects, and iron deficiency-related symptoms, compared to placebo. For the secondary objective, the effect of different iron supplementation protocols (i.e. frequency and dose) are investigated.
Study design: Randomized controlled trial
Study population: The study population will consist of 2,400 Dutch whole blood donors who have previously donated at least once before participation in this study. Seemingly healthy donors with ferritin levels of ≤30 μg/L will be selected. Donors that do not master the Dutch language will be excluded.
The study population for the mixed methods study will consist of frequent donors, potential new donors, and Sanquin Blood Bank staff. The frequent donors must have donated at least 5 times and did not participate in the randomized controlled trial. Furthermore, all participants must be fluent in Dutch to be able to participate.
Intervention: Donors will be randomly divided into 1 of 6 groups: (I) alternate day placebo supplementation, (II) daily placebo supplementation, (III) alternate day low dose iron supplementation, (IV) daily low dose iron supplementation, (V) alternate day high dose iron supplementation, and (VI) daily high dose iron supplementation.
Main study parameters/endpoints: The main study endpoints are ferritin and hemoglobin levels.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: At baseline, participants will visit one of the co-operating Sanquin locations to donate blood. Here, blood will be collected from the sampling pouch. During follow up visits at 56 days, 122 days, and 6 months blood will be collected by venipuncture. Both baseline and follow-up visits will not introduce any further risk than an ordinary blood donation and participation may have beneficial effects for the participants receiving supplements by reducing symptoms related to iron deficiency. However, iron supplementation could cause gastrointestinal discomfort. Furthermore blood samples will be taken more often, and donors will need to invest time to complete questionnaires and for the additional visits to the blood bank.
Study objective
Post-donation iron supplementation will be an effective strategy to enhance the iron status recovery in whole blood donors with low ferritin levels.
Study design
Baseline (t=0), first follow-up visit (t=56 days), second follow-visit (t=122 days), final follow-up visit (t=6 months)
Intervention
Iron supplementation
Inclusion criteria
- The donors must meet all the standard requirements to donate
- A ferritin measurement must be planned during the next donation
- The baseline donation must be succesful
- Ferritin level should be ≤ 30 µg/L
Exclusion criteria
- The donor does not master the Dutch language.
- The donor is currently or has in the last 3 months been taking iron supplements prescribed by their doctor.
Design
Recruitment
IPD sharing statement
Plan description
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8590 |
| Other | METC AMC : T.B.A. |