BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy (UH3BLIS)

University of Minnesota (UMN)

Status

Active, not recruiting

Conditions

Blood Donation

Treatments

Dietary Supplement: supplementation with low dose elemental iron

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06101238

UH3HL151599-04 (U.S. NIH Grant/Contract)

B08

Details and patient eligibility

About

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.

Enrollment

533 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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