Iron-deficiency AnemiaBLISNCT04949165
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
A study testing Iron Supplementation in people with Iron-deficiency Anemia and Iron-deficiency, run by University of Minnesota at 1 site in Ghana.
Trial summary
This pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (ID) and iron deficiency anaemia (IDA) among first-time donors, and 2) a longitudinal 2-arm parallel groups trial among first- time voluntary… Read more about this study
- Who is it for?
- Ages 17 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency Anemia, Iron-deficiency
- What is being tested?
- Iron Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteGhana
- Study dates
- 7 Sep 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males or females aged between 17 and 60 years who weigh at least 50kg.
- Pass pre-donation screening using the NBSG standardised donor screening questionnaire for medical conditions and lifestyle risks for transfusion transmissible infections
- Vital signs must meet the NBSG requirement for blood donation: systolic and diastolic blood pressures between 90-140 mmHg and 60- 90 mmHg, respectively; pulse rate between 50-100 bpm; non-contact forehead temperature not exceeding 37.5°C; meeting acceptable requirements for skin lesions, needle marks and physical appearance.
- Must be willing and able to give study consent or assent.
- Intend to remain in the study location/site during the entire length of the study.
Who cannot join
- Persons who have used iron supplementation within the past one month.
- Participant reports having previously donated blood.
- Evidence for a TTI at baseline among those who successfully donated.
- Evidence of Malaria and helminthic infections at baseline
- Participants who have Hb <10g/dl at screening
Trial locations and contacts
1 site in 1 country.
Ghana1 site
University of Ghana Medicial School, Department of Haematology
Accra
About this study
Official title: Iron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana
This pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (ID) and iron deficiency anaemia (IDA) among first-time donors, and 2) a longitudinal 2-arm parallel groups trial among first- time voluntary donors that compares haemoglobin levels at 4 months among those with ID or IDA who receive iron supplementation to those without ID or IDA who do not receive iron supplementation. A structured questionnaire will be used to extract demographic characteristics. Participants will be followed for a total of 6 months with study visits at 2, 4 and 6 months after the baseline assessments. Blood draws for full blood count (FBC), peripheral film comment, malaria rapid diagnostic tests (RDT) and ferritin assessment will occur at baseline and all follow-up visits. In addition, we will use a qualitative approach to identify barriers and facilitators of blood donation and the use of dietary and iron supplementation strategies to address iron deficiency and/or anaemia. This will involve conducting focus group discussions during the last month of the intervention and key informant interviews.
Expected Outcomes The expected outcomes of the study have been grouped into two, primary and secondary. Primary Outcome will be haemoglobin level after 4 months. Secondary Outcomes are A. Change in haemoglobin levels B. Diagnosis of ID or IDA at 4 months C. Serum ferritin concentration after 4 months of intervention D. Acceptability of iron supplementation among participants and stakeholders E. Incidence of gastrointestinal adverse events F. Incidence of suspected malaria or bacterial infections G. Incidence of ID and IDA H. Successful return (non-deferred) to the blood donor pool after intervention within 6 months of enrolment I. Key barriers and facilitators of intervention implementation.
- Conditions
- Iron-deficiency Anemia, Iron-deficiency
- Being tested
- Iron Supplementation
- Keywords
- Blood donation
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SupplementationDietary supplement
low dose ferrous sulphate (65mg elemental iron) supplements
| Study group | Role | What they receive |
|---|---|---|
| Iron Supplementation | Experimental | Not described Receives: Dietary Supplement: Iron Supplementation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin Level
Haemoglobin level at 4 months from the enrollment visit.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start7 Sep 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiency AnemiaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Blood Service Ghana, University of Ghana Medical School, Liverpool School of Tropical Medicine, Syracuse University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949165
- Sponsor's protocol ID
- 326045 - UG3HL151599
- Other IDs
- UG3HL151599
- Acronym
- BLIS
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2021
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
Segbefia C, Telke S, Olayemi E, Ward C, Asamoah-Akuoko L, Appiah B, Yawson AE, Tancred T, Adu-Afarwuah S, Benneh-Akwasi Kuma A, Acquah ME, Ofori-Acquah SF, Adongo PB, Ametorwo R, Bates I, Reilly C, Dei-Adomakoh Y; BLOODSAFE Ghana Investigators. Deferrals for Low Haemoglobin and Anaemia Among First-Time Prospective Blood Donors in Southern Ghana: Results From the BLOODSAFE Ghana-Iron and Nutritional Counselling Strategy Pilot (BLIS) Study. Adv Hematol. 2025 May 6;2025:9971532. doi: 10.1155/ah/9971532. eCollection 2025.
PubMed 40365600
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana
- ClinicalTrials.gov ID
- NCT04949165
- Acronym / sponsor ID
- BLIS / 326045 - UG3HL151599
- Conditions
- Iron-deficiency Anemia, Iron-deficiency
- Keywords
- Blood donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Blood Service Ghana, University of Ghana Medical School, Liverpool School of Tropical Medicine, Syracuse University
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (ID) and iron deficiency anaemia (IDA) among first-time donors, and 2) a longitudinal 2-arm parallel groups trial among first- time voluntary donors that compares haemoglobin levels at 4 months among those with ID or IDA who receive iron supplementation to those without ID or IDA who do not receive iron supplementation. A structured questionnaire will be used to extract demographic characteristics. Participants will be followed for a total of 6 months with study visits at 2, 4 and 6 months after the baseline assessments. Blood draws for full blood count (FBC), peripheral film comment, malaria rapid diagnostic tests (RDT) and ferritin assessment will occur at baseline and all follow-up visits. In addition, we will use a qualitative approach to identify barriers and facilitators of blood donation and the use of dietary and iron supplementation strategies to address iron deficiency and/or anaemia. This will involve conducting focus group discussions during the last month of the intervention and key informant interviews.
Expected Outcomes The expected outcomes of the study have been grouped into two, primary and secondary. Primary Outcome will be haemoglobin level after 4 months. Secondary Outcomes are A. Change in haemoglobin levels B. Diagnosis of ID or IDA at 4 months C. Serum ferritin concentration after 4 months of intervention D. Acceptability of iron supplementation among participants and stakeholders E. Incidence of gastrointestinal adverse events F. Incidence of suspected malaria or bacterial infections G. Incidence of ID and IDA H. Successful return (non-deferred) to the blood donor pool after intervention within 6 months of enrolment I. Key barriers and facilitators of intervention implementation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Supplementation | Experimental | Dietary Supplement: Iron Supplementation |
| Control | No intervention | – |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males or females aged between 17 and 60 years who weigh at least 50kg.
- Pass pre-donation screening using the NBSG standardised donor screening questionnaire for medical conditions and lifestyle risks for transfusion transmissible infections
- Vital signs must meet the NBSG requirement for blood donation: systolic and diastolic blood pressures between 90-140 mmHg and 60- 90 mmHg, respectively; pulse rate between 50-100 bpm; non-contact forehead temperature not exceeding 37.5°C; meeting acceptable requirements for skin lesions, needle marks and physical appearance.
- Must be willing and able to give study consent or assent.
- Intend to remain in the study location/site during the entire length of the study.
Key exclusion criteria (5 listed)
- Persons who have used iron supplementation within the past one month.
- Participant reports having previously donated blood.
- Evidence for a TTI at baseline among those who successfully donated.
- Evidence of Malaria and helminthic infections at baseline
- Participants who have Hb <10g/dl 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 |
|---|---|---|
| Iron Supplementationlow dose ferrous sulphate (65mg elemental iron) supplements | Dietary supplement | Iron Supplementation |
Primary outcome
Haemoglobin Level
Time frame: 4 months
Haemoglobin level at 4 months from the enrollment visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40365600Segbefia C, Telke S, Olayemi E, Ward C, Asamoah-Akuoko L, Appiah B, Yawson AE, Tancred T, Adu-Afarwuah S, Benneh-Akwasi Kuma A, Acquah ME, Ofori-Acquah SF, Adongo PB, Ametorwo R, Bates I, Reilly C, Dei-Adomakoh Y; BLOODSAFE Ghana Investigators. Deferrals for Low Haemoglobin and Anaemia Among First-Time Prospective Blood Donors in Southern Ghana: Results From the BLOODSAFE Ghana-Iron and Nutritional Counselling Strategy Pilot (BLIS) Study. Adv Hematol. 2025 May 6;2025:9971532. doi: 10.1155/ah/9971532. eCollection 2025.
- 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 Iron Supplementation in people with Iron-deficiency Anemia and Iron-deficiency, run by University of Minnesota at 1 site in Ghana.
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 5 inclusion and 5 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 31 Jul 2024. 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 Ghana. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Haemoglobin Level (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949165, which also lists 1 linked publication.
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 31 Jul 2024.