Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study

NCT04949165 | Completed Results DMC

• 2 other identifiers: 326045 - UG3HL151599UG3HL151599
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency Anemia; Iron-deficiency

Keywords

Blood donation

Outcome Measures

Primary Outcomes (1)

• Haemoglobin Level

  Haemoglobin level at 4 months from the enrollment visit.

  4 months

Study Arms (2)

Iron Supplementation

EXPERIMENTAL

Dietary Supplement: Iron Supplementation

Control

NO INTERVENTION

Interventions

Iron Supplementation DIETARY_SUPPLEMENT

low dose ferrous sulphate (65mg elemental iron) supplements

Iron Supplementation

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Ghana Medicial School, Department of Haematology

Accra, Ghana

Location

Related Publications (1)

• 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.

  PMID: 40365600 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Protocol Manager for BLIS
• Organization: University of Minnesota

telke001@umn.edu

(612)590-2697

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: September 7, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)