Clinical trial NCT06101238: BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Donation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: National Blood Service Ghana
name: Syracuse University
name: Liverpool School of Tropical Medicine
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-10-26
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with a successful blood donation
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of participants who attempt blood donation
timeFrame: 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: