Iron Depletion and Replacement in Blood Donors

August 31, 2021 updated by: Memorial Blood Centers, Minnesota
The purpose of this study is to determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron replacement therapy to donors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective study will be conducted under IRB approval at Memorial Blood Centers. Approximately 1000 donors will be enrolled over a two-year period.

Participant Recruitment Donors presenting to donate whole blood at MBC who have a Hb value between 12.5-13.5 (males) or 12.0-13.0 (females) will be asked to participate. Written informed consent will be obtained from each participant.

STUDY PROCEDURES MBC will be responsible for donor consenting, specimen collection and testing, donor deferral, donor-follow-up, and record keeping. Before any study participation, donors who meet the inclusion criteria will be required to sign and date an informed consent. All participants will receive a study information sheet and be asked screening questions and donor information.

An EDTA and red top tube will be taken from the diversion pouch of each participant during their donation, or obtained from samples already drawn for donor screening. The EDTA sample and red top tube will be used to determine baseline CBC and ferritin levels, respectively.

Female participants who have a Hb of 12.0-12.4 will not be allowed to donate per FDA regulations, but will be asked to have an EDTA and red top tube drawn to determine baseline CBC and ferritin levels, respectively.

Participants whose ferritin levels are <30 (males) or <20 (females) will be eligible for enrollment into the low ferritin group. Those with ferritin levels >30 (males) or >20 (females) will be enrolled into the low Hb only group. Females whose Hb was in the range of 12.0-12.4 and with ferritin levels >20 will not be followed.

Once ferritin levels are determined, participants in both groups will be contacted by a study nurse. Those in the low Hb only group will be notified of their results and allowed to return after a standard 56 day deferral. Those in the low ferritin group will be offered iron replacement therapy and deferred from blood donation for 112 days.

Oral Iron Replacement Therapy Participants in the low ferritin group will be offered 200 tablets of Ferrous gluconate 325 mg (36 mg elemental iron) sent by mail. Tablets will be in child proof containers. This amount and form of iron were chosen because of its ready accessibility over the counter in packs of 100 at low cost to donor/donor center. Also, the following anemia website suggests 60mg elemental iron daily, i.e. 2-3 iron tablets in divided doses daily.Participants will be instructed to take one at lunch and one at bedtime. Participants will be instructed to contact the study physician or study nurse immediately if any adverse events occur.

Between 25 and 35 days, the study physician or nurse will contact all participants in the low ferritin group to assess their compliance and tolerance with the iron replacement therapy using a standard instrument. Those with unacceptable intolerance to the ferrous gluconate may be offered carbonyl iron at this time, and re-interviewed between days 60 and 70 using the same instrument.

Participant Follow-Up Participants in both groups will be asked to return to donate after their deferral period. During their follow-up donation, participants will be asked to complete a follow-up questionnaire, and samples will again be taken to determine CBC and ferritin levels. Participants will be notified of their results. Statistical analysis will be performed to determine outcome measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Memorial Blood Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fingerstick Hb value of 12.5-13.5 (males) or 12.0-13.0 (females)
  • Meets all other blood donor inclusion criteria
  • =>18 years of age

Exclusion Criteria:

  • History or family history of hemochromatosis, colon cancer, intestinal polyps, or chronic gastrointestinal disease
  • Currently taking iron in a form other than a multivitamin
  • Currently on a chronic therapeutic use of NSAIDS or anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Ferrous gluconate 325mg
Those found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling.
Dietary supplement: Ferrous gluconate 325mg
Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.
Behavioral: Nutrition counseling
All blood donors receive current dietary counseling recommending iron rich foods
ACTIVE_COMPARATOR: Nutrition counseling
For those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation.
Behavioral: Nutrition counseling
All blood donors receive current dietary counseling recommending iron rich foods

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation
Time Frame: Two years
Subject self reported habits for taking iron supplement or iron rich diet and severity of gastrointestinal complaints (minimal-1 to severe-5). GI complaints were not separated by type for analysis.
Two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Improved Ferritin Levels on Subsequent Visit
Time Frame: Two years
Compared ferritin levels at baseline and after iron replacement therapy among blood donors, adjusting for time between visits, participant adherence levels, and whether a unit was donated at second visit.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Blood Centers, Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jed B. Gorlin, MD, MBA, Memorial Blood Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDAR-PN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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