BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-11

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Donation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Iron Supplementation

Group Type EXPERIMENTAL

supplementation with low dose elemental iron

Intervention Type DIETARY_SUPPLEMENT

65mg daily

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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supplementation with low dose elemental iron

65mg daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes