UH3BLIS: BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06101238
• Collaborator: University of Ghana (Other), National Blood Service Ghana (Other), Syracuse University (Other), Liverpool School of Tropical Medicine (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 492
• Arms: 2
• Anticipated Duration (Months): 30

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Donation	Dietary Supplement: supplementation with low dose elemental iron	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 492 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2026
• Anticipated Study Completion Date: Apr 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of participants with a successful blood donation [12 months]

Secondary Outcome Measures

1. Proportion of participants who attempt blood donation [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT06101238
• Other Study ID Numbers: b08; UG3HL151599
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 26, 2023