BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy

Blood Donation Clinical Trial

— UH3BLIS  

Official title:

BLOODSAFE- Implementation of Iron Supplementation and Nutritional Counselling Interventions to Improve Availability and Safety of Blood in Ghana-a Type I Pragmatic Effectiveness- Implementation Hybrid Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101238
• Other study ID #: B08
• Secondary ID: UH3HL151599-04
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: April 2026

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: Susan E Telke, MS
• Phone: (612) 590-2697
• Email: telke001[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized trial will compare 6-months of low-dose (65mg elemental iron daily) among prospective blood donors who are deferred for low haemoglobin but have passed all of the other pre-screening requirements for blood donation to a group of donors who were deferred from donating and receive the current standard of care (nutrition counseling only). An automated full blood count (FBC) will also be done to identify any safety concerns. The randomized trial will evaluate effectiveness with the primary outcome of at least one successful donation during a 12-month follow-up period. Safety will be evaluated by tracking iron supplementation related adverse events (e.g., lower gastrointestinal) and acceptability (e.g., compliance to study prescribed regimen) with monthly phone calls. Participants will be followed for a total of 12 months from screening with follow up phone calls at 4 weekly intervals. All participants will receive nutrition counselling and haemoglobin will be evaluated at screening. Individuals with very low haemoglobin (<10g/dl in females and <11g/dl in males) will be identified by an automated FBC at screening and referred for proper medical care. Sample size will be 264 per group: this gives 80% power for detecting an odds ratio of 2.6. With 2 donors recruited at each donation event, this will require 264 donation events. This corresponds to 2.5 donation events per week for 2 years or 2 donation events per week for 2.5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 492
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• individuals between 18 - 60 years who weigh at least 50kg
• pass pre-donation screening using the NBSG standardized donor screening questionnaire
• vital signs meet the NBSG requirement for blood donation
• non-contact forehead temperature not exceeding 37.5°C
• meeting acceptable requirements for skin lesions, needle marks and physical appearance.
• willingness and ability to consent
• understands one of English, Twi, Ewe, or Ga
• deferred for low haemoglobin
• intend to remain in the study during the entire length of the study

Exclusion Criteria:

• persons who have used iron supplementation within the past one month
• potential donors who are found to have haemoglobin Hb < 10g/dl (females) and Hb<11g/dl (males) at screening

Related Conditions & MeSH terms

• Blood Donation

Intervention

Dietary Supplement:
• supplementation with low dose elemental iron
65mg daily

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a successful blood donation		12 months
Secondary	Proportion of participants who attempt blood donation		12 months