Microbiome of Donor Iron Deficient Study

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

Detailed Description
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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.

Official Title
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Microbiome of Donor Iron Deficient Study (DIDS)

Conditions
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Iron Deficiency

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iron repletion<br>Subjects participating in the associated study under the Iron Repletion arm will also provide stool collection and answers to questionnaire and diet diary. | |
| Placebo<br>Subjects participating in the associated study under the Placebo arm will also provide stool collection and answers to questionnaire and diet diary. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfusion, Blood donation, Iron repletion