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| ID | Type | Description | Link |
|---|---|---|---|
| UH3HL151599-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Ghana | OTHER |
| National Blood Service Ghana | OTHER |
| Syracuse University | OTHER |
| Liverpool School of Tropical Medicine |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Supplementation | Experimental |
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| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supplementation with low dose elemental iron | Dietary Supplement | 65mg daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a successful blood donation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who attempt blood donation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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