Iron Supplementation for Blood Donors
(UH3BLIS Trial)
Trial Summary
Is iron supplementation safe for humans?
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 months of low-dose iron supplementation or standard nutrition counseling
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up phone calls at 4 weekly intervals
Treatment Details
Interventions
- Low Dose Elemental Iron
Low Dose Elemental Iron is already approved in United States, European Union, Canada for the following indications:
- Iron deficiency anemia
- Iron deficiency
- Iron deficiency anemia
- Iron deficiency
- Iron deficiency anemia
- Iron deficiency
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Syracuse University
Collaborator
University of Ghana
Collaborator
National Blood Service Ghana
Collaborator
Liverpool School of Tropical Medicine
Collaborator
National Blood Service Ghana
Collaborator