Ferritin-guided iron supplementation in whole blood donors: Optimal dosage, donor Response and reTurn and Efficacy (FORTE) - a randomized controlled trial
Recruiting
- Conditions
- IJzergebrek (Ferritine)Iron deficiency
- Registration Number
- NL-OMON54880
- Lead Sponsor
- Sanquin Bloedbank
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3000
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 <= 30 µg/L.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the effect of iron supplementation on the iron<br /><br>status (e.g. hemoglobin and ferritin) of the donors.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are symptoms related to iron deficiency, general<br /><br>health, donorship, compliance, lifestyle habits, side effects, and physical<br /><br>activity.</p><br>