Clinical trial NCT02990988: Microbiome of Donor Iron Deficient Study
Official title: Microbiome of Donor Iron Deficient Study (DIDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency
Keywords: Blood donation
Iron repletion
Transfusion
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with iron deficiency from blood donation will be recruited over 5 years in the associated randomized controlled trial conducted at Columbia University Medical Center.

Brief summary: The goal of this pilot study is to test whether the microbiome is affected by intravenous iron repletion.

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.

Eligibility 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.

Primary outcomes:
measure: Change in overall diversity of fecal flora
timeFrame: Baseline, 5-days, 4-weeks, 5 months
measure: Change in fecal indoles
timeFrame: Baseline, 5-days, 4-weeks, 5 months
measure: Change in fecal iron
timeFrame: Baseline, 5-days, 4-weeks, 5 months
Secondary outcomes:
measure: Mean Bray-Curtis indices
timeFrame: Baseline, 5-days, 4-weeks, 5 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
name: Eldad Hod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith GA, Fisher SA, Doree 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.
citation: 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. doi: 10.1111/j.1537-2995.2006.00969.x. No abstract available.
citation: 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.
citation: 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.
citation: Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x. No abstract available.