BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy (UH3BLIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Donation
• Intervention / Treatment: Dietary supplement: supplementation with low dose elemental iron

• Study Type: Interventional
• Enrollment (Actual): 533
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: Iron Supplementation	Dietary supplement: supplementation with low dose elemental iron; 65mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with a successful blood donation	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who attempt blood donation	12 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Ghana; Syracuse University; Liverpool School of Tropical Medicine; National Blood Service Ghana

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Actual): February 26, 2026
• Study Completion (Actual): February 26, 2026

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: B08; UH3HL151599-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No