BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy

NCT06101238 | Active Not Recruiting DMC

• 2 other identifiers: B08UH3HL151599-04
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Donation

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with a successful blood donation

  12 months

Secondary Outcomes (1)

• Proportion of participants who attempt blood donation

  12 months

Study Arms (2)

Iron Supplementation

EXPERIMENTAL

Dietary Supplement: supplementation with low dose elemental iron

Standard of Care

NO INTERVENTION

Interventions

supplementation with low dose elemental iron DIETARY_SUPPLEMENT

65mg daily

Iron Supplementation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 26, 2023
• Study Start: January 11, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)