Blood DonationUH3BLISNCT06101238
BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy
A study testing supplementation with low dose elemental iron in people with Blood Donation, run by University of Minnesota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Donation
- What is being tested?
- supplementation with low dose elemental iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals between 18 - 60 years who weigh at least 50kg
- pass pre-donation screening using the NBSG standardized donor screening questionnaire
- vital signs meet the NBSG requirement for blood donation
- non-contact forehead temperature not exceeding 37.5°C
- meeting acceptable requirements for skin lesions, needle marks and physical appearance.
- willingness and ability to consent
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- understands one of English, Twi, Ewe, or Ga
- deferred for low haemoglobin
- intend to remain in the study during the entire length of the study
Who cannot join
- persons who have used iron supplementation within the past one month
- potential donors who are found to have haemoglobin Hb < 10g/dl (females) and Hb<11g/dl (males) at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: BLOODSAFE- Implementation of Iron Supplementation and Nutritional Counselling Interventions to Improve Availability and Safety of Blood in Ghana-a Type I Pragmatic Effectiveness- Implementation Hybrid 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.
- Conditions
- Blood Donation
- Being tested
- supplementation with low dose elemental iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation with low dose elemental ironDietary supplement
65mg daily
| Study group | Role | What they receive |
|---|---|---|
| Iron Supplementation | Experimental | Not described Receives: Dietary Supplement: supplementation with low dose elemental iron |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a successful blood donation
Measured: 12 months
Secondary outcomes (1)
Proportion of participants who attempt blood donation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start11 Jan 2024
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, National Blood Service Ghana, Syracuse University, Liverpool School of Tropical Medicine, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101238
- Sponsor's protocol ID
- B08
- Other IDs
- UH3HL151599-04
- Acronym
- UH3BLIS
- Status last verified
- May 2026
- First submitted
- 11 Oct 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOODSAFE- Implementation of Iron Supplementation and Nutritional Counselling Interventions to Improve Availability and Safety of Blood in Ghana-a Type I Pragmatic Effectiveness- Implementation Hybrid Trial
- ClinicalTrials.gov ID
- NCT06101238
- Acronym / sponsor ID
- UH3BLIS / B08
- Conditions
- Blood Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Ghana, National Blood Service Ghana, Syracuse University, Liverpool School of Tropical Medicine, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Supplementation | Experimental | Dietary Supplement: supplementation with low dose elemental iron |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- individuals between 18 - 60 years who weigh at least 50kg
- pass pre-donation screening using the NBSG standardized donor screening questionnaire
- vital signs meet the NBSG requirement for blood donation
- non-contact forehead temperature not exceeding 37.5°C
- meeting acceptable requirements for skin lesions, needle marks and physical appearance.
Key exclusion criteria (2 listed)
- persons who have used iron supplementation within the past one month
- potential donors who are found to have haemoglobin Hb < 10g/dl (females) and Hb<11g/dl (males) at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementation with low dose elemental iron65mg daily | Dietary supplement | Iron Supplementation |
Primary outcome
Proportion of participants with a successful blood donation
Time frame: 12 months
1 secondary outcome
Proportion of participants who attempt blood donation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation with low dose elemental iron in people with Blood Donation, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a successful blood donation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.