Completed

BLISIron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana

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What is being tested

Iron Supplementation

Dietary Supplement
Who is being recruted

Iron Deficiencies+6

+ Anemia

+ Anemia, Hypochromic

From 17 to 60 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 7, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleIron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana
NCT04949165
Principal SponsorUniversity of Minnesota
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

223 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 17 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesAnemiaAnemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, Iron-DeficiencyIron Metabolism Disorders

Criteria

5 inclusion criteria required to participate
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.

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5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Ghana Medicial School, Department of Haematology

Accra, GhanaOpen University of Ghana Medicial School, Department of Haematology in Google Maps
CompletedOne Study Center