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NCT06101238 · ClinicalTrials.gov registry record · NA
BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy
A NA study of Blood Donation, sponsored by University of Minnesota.
- Active
- Registry status
- NA
- Development phase
- 533
- Enrollment target
- 1
- Study location
NCT06101238 is a NA study of Blood Donation that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 533 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06101238, a NA study of Blood Donation, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 533 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT supplementation with low dose elemental iron
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 533 participants |
| Start Date | 2024-01-11 |
| Est. Completion | 2026-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06101238
The ClinicalTrials.gov registry entry for NCT06101238 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 533 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Blood Donation appearing as the primary indexed condition, and to 1 intervention - of which supplementation with low dose elemental iron is the first listed.
NCT06101238 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06101238 about?
NCT06101238 is a clinical study titled "BLOODSAFE Ghana- Iron and Nutritional Counselling Strategy". 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 cur...
What is the current status of trial NCT06101238?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 533 participants. The study started on 2024-01-11. Estimated completion is 2026-04.
What conditions does trial NCT06101238 study?
This clinical trial studies the following conditions: Blood Donation.
What interventions are being tested in trial NCT06101238?
The interventions under investigation include: supplementation with low dose elemental iron (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06101238?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101238 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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