Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study

Iron-deficiency Clinical Trial

— BLIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949165
• Other study ID #: 326045 - UG3HL151599
• Secondary ID: UG3HL151599
• Status: Completed
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency
• Iron-deficiency Anemia

Intervention

Dietary Supplement:
• Iron Supplementation
low dose ferrous sulphate (65mg elemental iron) supplements

Locations

Country	Name	City	State
Ghana	University of Ghana Medicial School, Department of Haematology	Accra

Sponsors (6)

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

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin level		4 months