Microbiome of Donor Iron Deficient Study

Iron Deficiency Clinical Trial

Official title:

Microbiome of Donor Iron Deficient Study (DIDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990988
• Other study ID #: AAAR1265
• Status: Completed
• Start date: January 2017
• Est. completion date: June 3, 2022

Study information

• Verified date: September 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in overall diversity of fecal flora	Stool samples will be collected and processed.	Baseline, 5-days, 4-weeks, 5 months
Primary	Change in fecal indoles	Indole concentrations measured in fecal samples	Baseline, 5-days, 4-weeks, 5 months
Primary	Change in fecal iron	Iron concentrations measured in fecal samples	Baseline, 5-days, 4-weeks, 5 months
Secondary	Mean Bray-Curtis indices	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.	Baseline, 5-days, 4-weeks, 5 months