Microbiome of Donor Iron Deficient Study
Study Details
Study Description
Brief Summary
The goal of this pilot study is to test whether the microbiome is affected by intravenous iron repletion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The colonic microbiome, the community of bacteria living in our gut, is essential in human health and disease. Iron is an essential nutrient for both bacteria and humans. In the United States, of the donors who provided the ~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized controlled trial, recruiting 60 healthy regular donors who meet donation standards, while exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary study, we will determine what effect donor iron deficiency and IV iron repletion have on the gut microbiome.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Iron repletion Subjects participating in the associated study under the Iron Repletion arm will also provide stool collection and answers to questionnaire and diet diary. |
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| Placebo Subjects participating in the associated study under the Placebo arm will also provide stool collection and answers to questionnaire and diet diary. |
Outcome Measures
Primary Outcome Measures
- Change in overall diversity of fecal flora [Baseline, 5-days, 4-weeks, 5 months]
Stool samples will be collected and processed.
- Change in fecal indoles [Baseline, 5-days, 4-weeks, 5 months]
Indole concentrations measured in fecal samples
- Change in fecal iron [Baseline, 5-days, 4-weeks, 5 months]
Iron concentrations measured in fecal samples
Secondary Outcome Measures
- Mean Bray-Curtis indices [Baseline, 5-days, 4-weeks, 5 months]
Calculation of Bray-Curtis index will determine the relative abundance of specific taxa (e.g., Firmicutes, Bacteroidetes, Proteobacteria) for each subject. Means (of the differences in %) and standard deviations will be calculated for all comparisons, and a multivariable generalized estimating equations (GEE) model will be used to test for significance.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).
Exclusion Criteria:
- Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10023 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Eldad Hod, MD, Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Study Documents (Full-Text)
None provided.More Information
Publications
- Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.
- Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x.
- Cable RG, Glynn SA, Kiss JE, Mast AE, Steele WR, Murphy EL, Wright DJ, Sacher RA, Gottschall JL, Tobler LH, Simon TL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Iron deficiency in blood donors: the REDS-II Donor Iron Status Evaluation (RISE) study. Transfusion. 2012 Apr;52(4):702-11. doi: 10.1111/j.1537-2995.2011.03401.x. Epub 2011 Oct 24.
- Newman B. Iron depletion by whole-blood donation harms menstruating females: the current whole-blood-collection paradigm needs to be changed. Transfusion. 2006 Oct;46(10):1667-81. Review.
- Smith GA, Fisher SA, Dorée C, Roberts DJ. A systematic review of factors associated with the deferral of donors failing to meet low haemoglobin thresholds. Transfus Med. 2013 Oct;23(5):309-20. doi: 10.1111/tme.12046. Epub 2013 Jul 5. Review.
- AAAR1265