528 Participants Needed

Iron Supplementation for Blood Donors

(UH3BLIS Trial)

SE
Overseen BySusan E Telke, MS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Is iron supplementation safe for humans?

Iron supplements, like ferrous sulfate, can cause side effects such as diarrhea, increased risk of infections like malaria, and gut inflammation. However, some forms of iron, like those in wax-matrix tablets, may have fewer side effects compared to conventional tablets.123

How is the drug Low Dose Elemental Iron unique for blood donors?

Low Dose Elemental Iron, such as ferrous sulfate, is unique for blood donors because it helps replenish iron levels after donation, reducing the risk of iron depletion. Unlike other forms of iron, ferrous sulfate is known to significantly increase iron levels in the body, making it effective for maintaining iron reserves in frequent donors.14567

What is the purpose of this trial?

A randomized trial will compare 6-months of low-dose (65mg elemental iron daily) among prospective blood donors who are deferred for low haemoglobin but have passed all of the other pre-screening requirements for blood donation to a group of donors who were deferred from donating and receive the current standard of care (nutrition counseling only). An automated full blood count (FBC) will also be done to identify any safety concerns. The randomized trial will evaluate effectiveness with the primary outcome of at least one successful donation during a 12-month follow-up period. Safety will be evaluated by tracking iron supplementation related adverse events (e.g., lower gastrointestinal) and acceptability (e.g., compliance to study prescribed regimen) with monthly phone calls. Participants will be followed for a total of 12 months from screening with follow up phone calls at 4 weekly intervals. All participants will receive nutrition counselling and haemoglobin will be evaluated at screening. Individuals with very low haemoglobin (\<10g/dl in females and \<11g/dl in males) will be identified by an automated FBC at screening and referred for proper medical care.Sample size will be 264 per group: this gives 80% power for detecting an odds ratio of 2.6. With 2 donors recruited at each donation event, this will require 264 donation events. This corresponds to 2.5 donation events per week for 2 years or 2 donation events per week for 2.5 years.

Eligibility Criteria

This trial is for individuals aged 18-60, weighing at least 50kg, who meet the physical criteria for blood donation but were deferred due to low haemoglobin. They must understand English, Twi, Ewe, or Ga and be willing to stay in the study for its full length.

Inclusion Criteria

I plan to stay in the study for its full duration.
You have successfully completed the National Blood Supply Group's pre-donation screening questionnaire.
Your non-contact forehead temperature must be below 37.5°C.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive 6 months of low-dose iron supplementation or standard nutrition counseling

6 months
Monthly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up phone calls at 4 weekly intervals

12 months
Phone calls every 4 weeks

Treatment Details

Interventions

  • Low Dose Elemental Iron
Trial Overview The trial compares a group taking low-dose iron supplements daily with those receiving only nutrition counseling after being deferred from blood donation due to low haemoglobin. Success is measured by their ability to donate blood within a year.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Iron SupplementationExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Low Dose Elemental Iron is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Elemental iron for:
  • Iron deficiency anemia
  • Iron deficiency
🇪🇺
Approved in European Union as Elemental iron for:
  • Iron deficiency anemia
  • Iron deficiency
🇨🇦
Approved in Canada as Elemental iron for:
  • Iron deficiency anemia
  • Iron deficiency

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Syracuse University

Collaborator

Trials
54
Recruited
118,000+

University of Ghana

Collaborator

Trials
48
Recruited
119,000+

National Blood Service Ghana

Collaborator

Trials
4
Recruited
1,800+

Liverpool School of Tropical Medicine

Collaborator

Trials
96
Recruited
804,000+

National Blood Service Ghana

Collaborator

Trials
4
Recruited
1,800+

Findings from Research

Oral iron supplementation with ferrous sulfate (FeSO₄) leads to significantly higher levels of non-transferrin-bound iron (NTBI) in the bloodstream compared to other iron compounds, which raises safety concerns for young children with malaria.
In contrast, iron compounds like sodium iron ethylenediaminetetraacetic acid (NaFeEDTA) and iron polymaltose show negligible NTBI responses, suggesting they may be safer alternatives for iron supplementation in areas where malaria is prevalent.
Oral administration of ferrous sulfate, but not of iron polymaltose or sodium iron ethylenediaminetetraacetic acid (NaFeEDTA), results in a substantial increase of non-transferrin-bound iron in healthy iron-adequate men.Schümann, K., Solomons, NW., Romero-Abal, ME., et al.[2022]
In a study involving 543 participants, the wax-matrix tablet of ferrous sulfate was associated with significantly fewer adverse effects compared to conventional ferrous sulfate tablets.
Eighty-one percent of participants using the wax-matrix preparation reported no severe or moderate side effects, while only 50% of those taking the conventional tablets had the same experience, indicating better tolerability of the wax-matrix formulation.
Adverse effects of iron supplementation: a comparative trial of a wax-matrix iron preparation and conventional ferrous sulfate tablets.Brock, C., Curry, H., Hanna, C., et al.[2014]
The 'Safe Iron Study' is the first clinical trial to evaluate the safety and efficacy of novel iron supplements, comparing them to traditional ferrous sulfate in healthy adults, aiming to address the adverse effects associated with current iron treatments.
The study will assess whether these new iron forms can improve iron status without increasing risks of malaria, bacterial infections, or gut inflammation, potentially leading to safer options for treating iron deficiency and anemia.
Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study.Lewis, ED., Wu, D., Mason, JB., et al.[2023]

References

Oral administration of ferrous sulfate, but not of iron polymaltose or sodium iron ethylenediaminetetraacetic acid (NaFeEDTA), results in a substantial increase of non-transferrin-bound iron in healthy iron-adequate men. [2022]
Adverse effects of iron supplementation: a comparative trial of a wax-matrix iron preparation and conventional ferrous sulfate tablets. [2014]
Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study. [2023]
Iron supplementation by blood donors: demographics, patterns of use, and motivation. [2020]
A laboratory report on iron supplementation in blood donors. I. [2019]
Iron supplementation in female blood donors deferred by copper sulfate screening. [2019]
Hepcidin/Ferritin Quotient Helps to Predict Spontaneous Recovery from Iron Loss following Blood Donation. [2020]
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