Iron supplementation and nutritional counseling for blood donors in Ghana
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
This study tests if giving low-dose iron supplements along with nutrition advice can help people in Ghana who were turned away from donating blood due to low hemoglobin levels successfully donate blood after a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 528 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06101238 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of low-dose iron supplementation combined with nutritional counseling for prospective blood donors who have been deferred due to low hemoglobin levels. Participants will be randomly assigned to receive either the iron supplementation or standard nutritional counseling alone. The study will track the number of successful blood donations over a 12-month period, while also monitoring safety and compliance through regular follow-up calls. An automated full blood count will be conducted to ensure participant safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-60 who have been deferred from blood donation due to low hemoglobin but meet all other pre-screening requirements.
Not a fit: Patients who have recently used iron supplements or have significantly low hemoglobin levels at screening will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could increase the number of eligible blood donors and improve blood donation rates.
How similar studies have performed: Other studies have shown promising results with iron supplementation in improving hemoglobin levels among blood donors, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Susan E Telke, MS
- Email: telke001@umn.edu
- Phone: (612) 590-2697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.