Ferritin-guided iron supplementation in whole blood donors: Optimal dosage, donor Response and reTurn and Efficacy (FORTE) - a randomized controlled trial

Ferritin-guided iron supplementation in whole blood donors: Optimal dosage, donor Response and reTurn and Efficacy (FORTE) - a randomized controlled trial - FORTE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54880

Enrollment

3000

Registered

2021-06-02

Start date

2021-07-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IJzergebrek (Ferritine) Iron deficiency

Interventions

56 days of supplementation with iron or placebo capsules: - Every other day supplementation with low-dose iron capsules - Daily supplementation with low-dose iron capsules - Every other day supplemen

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For the baseline questionnaire/measurement -Whole blood donors should donate at one of the participating Sanquin locations. -A ferritin measurement should be planned for their next donation. For participation in the trial -Successfully donated whole blood at baseline. -Ferritin level should be

Exclusion criteria

Exclusion criteria: -Donors who do not master the Dutch language. -Donors who are currently or in the last 3 months supplemented with iron prescribed by their doctor can't participate in the trial.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the effect of iron supplementation on the iron status (e.g. hemoglobin and ferritin) of the donors.	—

Secondary

Measure	Time frame
Secondary outcome measures are symptoms related to iron deficiency, general health, donorship, compliance, lifestyle habits, side effects, and physical activity.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)