NCT02990988

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

5.4 years

First QC Date

December 9, 2016

Last Update Submit

September 15, 2022

Conditions

Iron Deficiency

Keywords

Blood donationIron repletionTransfusion

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Mean Bray-Curtis indices

    Baseline, 5-days, 4-weeks, 5 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10023, United States

Location

Related Publications (5)

  • Smith GA, Fisher SA, Doree 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.

    PMID: 23829880BACKGROUND

  • 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. doi: 10.1111/j.1537-2995.2006.00969.x. No abstract available.

    PMID: 17002622BACKGROUND

  • 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.

    PMID: 25469720BACKGROUND

  • 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.

    PMID: 22023513BACKGROUND

  • Brittenham GM. Iron deficiency in whole blood donors. Transfusion. 2011 Mar;51(3):458-61. doi: 10.1111/j.1537-2995.2011.03062.x. No abstract available.

    PMID: 21388389BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool collection

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eldad Hod, MD

    Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2016

First Posted

December 13, 2016

Study Start

January 1, 2017

Primary Completion

June 3, 2022

Study Completion

June 3, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)