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Microbiome of Donor Iron Deficient Study

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ClinicalTrials.gov Identifier: NCT02990988
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Columbia University

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

Condition or disease
Iron Deficiency

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Microbiome of Donor Iron Deficient Study (DIDS)
Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort
Iron repletion
Subjects participating in the associated study under the Iron Repletion arm will also provide stool collection and answers to questionnaire and diet diary.
Placebo
Subjects participating in the associated study under the Placebo arm will also provide stool collection and answers to questionnaire and diet diary.



Primary Outcome Measures :
  1. Change in overall diversity of fecal flora [ Time Frame: Baseline, 5-days, 4-weeks, 5 months ]
    Stool samples will be collected and processed.


Secondary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Stool collection


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990988


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10023
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Eldad Hod, MD Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Study Data/Documents: Survey Report  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02990988    
Other Study ID Numbers: AAAR1265
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Columbia University:
Blood donation
Iron repletion
Transfusion
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases