Treatment for Iron Deficiency (ID)

Phase-Based Estimates
1
Effectiveness
1
Safety
Columbia University Medical Center, New York, NY
+1 More
Eligibility
18+
All Sexes
Eligible conditions
Iron Deficiency (ID)

Study Summary

Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality

See full description

Eligible Conditions

  • Anemia, Iron-Deficiency
  • Iron Deficiency (ID)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 20 secondary outcomes in patients with Iron Deficiency (ID). Measurement will happen over the course of Day 0-end of participation (e.g., ~6 months).

Month 6
Beck Anxiety Inventory (BAI) score
Beck Depression Inventory (BDI) II score
Global Fatigue Index (GFI) score
Hemoglobin
Hepcidin
RBC zinc protoporphyrin levels
Restless Legs Syndrome Rating Scale score
Reticulocyte Hemoglobin
SF-36 Emotional well-being score
SF-36 Energy/fatigue score
SF-36 General health score
SF-36 Health change score
SF-36 Pain score
SF-36 Physical functioning score
SF-36 Role functioning/emotional score
SF-36 Role functioning/physical score
SF-36 Social functioning score
Serum ferritin
Soluble transferrin receptor
Transferrin saturation
Day 42
51-Chromium 24-hour post-transfusion RBC recovery of units

Trial Safety

Trial Design

2 Treatment Groups

Iron repletion
Placebo group

This trial requires 85 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Iron repletionSubjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR.
PlaceboSubjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: performed 42 days after blood donation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly performed 42 days after blood donation for reporting.

Who is running the study

Principal Investigator
E. A. H.
Prof. Eldad Arie Hod, Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Columbia University

Closest Location

Columbia University Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18-75 years old;
healthy (by self report);
body weight >110 lbs;
female hematocrit >=38%, male hematocrit >39%;
frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
ferritin <=15 ng/mL;
zinc protoporphyrin >=60 µmol/mol heme.

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Iron Deficiency (ID) by sharing your contact details with the study coordinator.