Iron Deficiency Clinical Trial
— DIDSOfficial title:
A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery
Verified date | June 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary Hypothesis - The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use. - The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.
Status | Completed |
Enrollment | 79 |
Est. completion date | October 5, 2021 |
Est. primary completion date | October 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. 18-75 years old; 2. healthy (by self report); 3. body weight >110 lbs; 4. female hematocrit >=38%, male hematocrit >39%; 5. frequent blood donor (men =2 and female =1 RBC unit donations in past year); 6. ferritin <=15 ng/mL; and 7. zinc protoporphyrin >=60 µmol/mol heme. Exclusion Criteria: 1. ineligible for donation based on the New York Blood Center donor autologous questionnaire; 2. taking iron supplementation; 3. C-reactive protein >10 mg/L; 4. sickle cell trait; 5. systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg; 6. heart rate <50 or >100; 7. temperature >99.5°F prior to donation; 8. temperature >100.4°F or subjective feeling of illness prior to 51-Chromium 24-hour RBC recovery study (to avoid the subject having a concurrent illness that may affect post-transfusion recovery); 9. positive results on standard blood donor infectious disease testing; 10. pregnancy; 11. taking, or planning to take, iron supplements; and 12. history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis. |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Heart, Lung, and Blood Institute (NHLBI), New York Blood Center |
United States,
Moroff G, Sohmer PR, Button LN. Proposed standardization of methods for determining the 24-hour survival of stored red cells. Transfusion. 1984 Mar-Apr;24(2):109-14. doi: 10.1046/j.1537-2995.1984.24284173339.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 51-Chromium 24-hour Post-transfusion RBC Recovery of Units | Comparison of the percentage change in 51-Chromium-labeled RBCs remaining from pre- and 24 hour post-transfusion measurement between the Iron Repletion and the Placebo group. The post-transfusion recovery represents the percent of 51-Chromium-labeled RBCs remaining in circulation 24 hours after infusion as compared to an extrapolated time zero measurement. | Performed 42 days after blood donation | |
Secondary | RBC Zinc Protoporphyrin Levels | Measured in a clinical laboratory. Will be used to determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery along with the effect of treatment on zinc protoporphyrin levels. | End of participation (e.g., ~6 months) | |
Secondary | Serum Ferritin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation ferritin levels and post-transfusion recovery along with the effect of treatment on ferritin levels. | End of participation (e.g., ~6 months) | |
Secondary | Hemoglobin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation hemoglobin levels and post-transfusion recovery along with the effect of treatment on hemoglobin levels. | End of participation (e.g., ~6 months) | |
Secondary | Reticulocyte Hemoglobin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation reticulocyte hemoglobin levels and post-transfusion recovery along with the effect of treatment on reticulocyte hemoglobin levels. | End of participation (e.g., ~6 months) | |
Secondary | Soluble Transferrin Receptor | Measured in a clinical laboratory. Will be used to determine the association between pre-donation soluble transferrin receptor levels and post-transfusion recovery along with the effect of treatment on soluble transferrin receptor levels. | End of participation (e.g., ~6 months) | |
Secondary | Hepcidin | Measured as a research use only test in a research laboratory using an ELISA from Intrinsic LifeSciences. Will be used to determine the association between pre-donation hepcidin levels and post-transfusion recovery along with the effect of treatment on hepcidin levels. | End of participation (e.g., ~6 months) | |
Secondary | Transferrin Saturation | Measured in a clinical laboratory. Will be used to determine the association between pre-donation transferrin saturation levels and post-transfusion recovery along with the effect of treatment on transferrin saturation levels. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Physical Functioning Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Role Functioning/Physical Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Role Functioning/Emotional Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Energy/Fatigue Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Emotional Well-being Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Social Functioning Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Pain Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 General Health Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | SF-36 Health Change Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) | |
Secondary | Beck Depression Inventory (BDI) II Score | Evaluating subjects' depression using the Beck Depression Inventory-II survey. Scores range from 0-63 with higher scores indicating more severe depression. | End of participation (e.g., ~6 months) | |
Secondary | Beck Anxiety Inventory (BAI) Score | Evaluating subjects' anxiety using the Beck Anxiety Inventory survey. Scores range from 0-63 with higher scores indicating more severe anxiety. | End of participation (e.g., ~6 months) | |
Secondary | Global Fatigue Index (GFI) Score | Evaluating subjects' fatigue using the Multidimensional Assessment of Fatigue (MAF) survey. Scores range from 1-50 with higher scores indicating more severe fatigue. | End of participation (e.g., ~6 months) | |
Secondary | Restless Legs Syndrome Rating Scale Score | Evaluating subjects' symptoms of restless leg syndrome using the Restless Legs Syndrome Rating Scale survey. Scores range from 0-40 with higher scores indicating more severe symptoms. | End of participation (e.g., ~6 months) |
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