Clinical trial NCT04949165: Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
Official title: Iron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency Anemia
Iron-deficiency
Keywords: Blood donation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Blood Service Ghana
name: University of Ghana Medical School
name: Liverpool School of Tropical Medicine
name: Syracuse University
First posted: 2021-07-02
Enrollment: 223
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Haemoglobin Level
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana Medicial School, Department of Haematology
Study officials:
References: