N/A
N=197
Iron Depletion and Replacement in Blood Donors
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01752413 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation — 116; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ferrous gluconate 325mg (Dietary_supplement); Nutrition counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Blood Centers, Minnesota
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation |
116; 17 | — |
| SECONDARY Number of Participants With Improved Ferritin Levels on Subsequent Visit |
73; 6 | — |
Summary
The purpose of this study is to determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron replacement therapy to donors.
Eligibility Criteria
Inclusion Criteria
- Fingerstick Hb value of 12.5-13.5 (males) or 12.0-13.0 (females)
- Meets all other blood donor inclusion criteria
- =>18 years of age
Exclusion Criteria
- History or family history of hemochromatosis, colon cancer, intestinal polyps, or chronic gastrointestinal disease
- Currently taking iron in a form other than a multivitamin
- Currently on a chronic therapeutic use of NSAIDS or anticoagulants
Data sourced from ClinicalTrials.gov (NCT01752413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.