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Completed

NCT Number: NCT02990988

Microbiome of Donor Iron Deficient Study

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10023, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in overall diversity of fecal flora

    Time frame: Baseline, 5-days, 4-weeks, 5 months

    Stool samples will be collected and processed.

  2. Change in fecal indoles

    Time frame: Baseline, 5-days, 4-weeks, 5 months

    Indole concentrations measured in fecal samples

  3. Change in fecal iron

    Time frame: Baseline, 5-days, 4-weeks, 5 months

    Iron concentrations measured in fecal samples

Secondary outcomes

  1. Mean Bray-Curtis indices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Microbiome of Donor Iron Deficient Study (DIDS)

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2016
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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