Microbiome of Donor Iron Deficient Study

Completed

• Conditions: Iron Deficiency

• Registration Number: NCT02990988
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Study Start: 2017-01
• Primary Completion: 2022-06-03
• Study Completion: 2022-06-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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).

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Exclusion Criteria

• Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in fecal indoles	Baseline, 5-days, 4-weeks, 5 months	Indole concentrations measured in fecal samples
Change in overall diversity of fecal flora	Baseline, 5-days, 4-weeks, 5 months	Stool samples will be collected and processed.
Change in fecal iron	Baseline, 5-days, 4-weeks, 5 months	Iron concentrations measured in fecal samples

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States