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Iron Replacement in Blood Donors

NCT00327067 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1820

Last updated 2017-07-02

No results posted yet for this study

Summary

Blood donors who have a low fingerstick hemoglobin level are usually deferred from donating. A possible solution to the problem of repeated deferrals might be for Blood Banks to offer donors with low hemoglobin levels oral iron supplements. To determine the feasibility of such a program, this study will:

* Determine the frequency of iron deficiency in first-time and repeat blood donors
* Examine the effects of long-term blood donation on donor hemoglobin levels and iron stores
* Compare body iron stores in donors who have low hemoglobin values with that of donors who have acceptable hemoglobin values at the time of donation
* Determine what conditions other than iron deficiency lead to low hemoglobin levels in blood donors
* Determine the safety and effectiveness of giving oral iron tablets to donors with low hemoglobin levels
* Monitor the effect of oral iron administration on donor satisfaction and donor retention.

First-time and repeat blood donors at the NIH Clinical Center Blood Bank 18 years of age and older may be eligible for this study. Participants include prospective donors who have an acceptable hemoglobin value at the time of donation and those whose hemoglobin level is determined to be too low for donation.

All participants do the following:

* Answer medical questions about their diet, health, and family history of blood disorders.
* Have blood samples drawn from their arm for testing blood cell counts, iron stores, and other hemoglobin-related tests as appropriate.

Donors with low hemoglobin also:

* Take iron supplements (ferrous sulfate) to replenish iron stores. (Donors who have previously had unpleasant side effects from ferrous sulfate are offered ferrous gluconate as an alternative.)
* Undergo evaluation with medical screening and laboratory tests at the time of future blood donations.

Conditions

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Stephen J O'Brien, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-12
Completion
2012-03-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327067 on ClinicalTrials.gov