Blood Donation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsupplementation with low dose elemental iron
65mg daily
Sponsors
University of Minnesota
University of Ghana
National Blood Service Ghana
Syracuse University
Liverpool School of Tropical Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with a successful blood donation | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who attempt blood donation | 12 months |
Countries
United States
Outcome results
None listed