Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study

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.

Conditions

• Iron-deficiency Anemia
• Iron-deficiency

Interventions

DIETARY_SUPPLEMENT

Iron Supplementation

low dose ferrous sulphate (65mg elemental iron) supplements

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Blood Service Ghana

  collaborator OTHER

• University of Ghana Medical School

  collaborator OTHER

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Syracuse University

  collaborator OTHER

• University of Minnesota

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

17 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-07

Primary Completion

2023-05-31

Completion

2023-05-31

Countries

• Ghana

Study Locations