Skip to main content
OpenTrials
Completed

NCT Number: NCT04949165

Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ghana Medicial School, Department of Haematology

Accra, Ghana

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron supplementation

Dietary Supplement

low dose ferrous sulphate (65mg elemental iron) supplements

Primary outcomes

  1. Haemoglobin Level

    Time frame: 4 months

    Haemoglobin level at 4 months from the enrollment visit.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Liverpool School of Tropical Medicine
  • National Blood Service Ghana
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Syracuse University
  • University of Ghana Medical School

Registry information

Official study title

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

Acronym: BLIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.