BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy

Not Applicable

Recruiting

• Conditions: Blood Donation
• Interventions: Dietary Supplement: supplementation with low dose elemental iron

• Registration Number: NCT06101238
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-26
• Study Start: 2024-01-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 528

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron Supplementation	supplementation with low dose elemental iron	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with a successful blood donation	12 months

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who attempt blood donation	12 months

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States