Hemoglobin and Iron Recovery Study (HEIRS)

January 22, 2014 updated by: National Heart, Lung, and Blood Institute (NHLBI)
The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effect of taking iron supplements after blood donation on time to recovery of hemoglobin has been documented but it is not clear whether the benefits of iron supplements vary with age, gender or iron stores. To study this issue, individuals who are eligible to donate blood, based on hemoglobin level, will be randomized to receive daily iron supplements or no supplements. Randomization will be stratified on gender (male or female), age (<60 years old vs. at least 60 years old) and iron status (serum ferritin >26 vs serum ferritin no greater than 26). Subjects will be followed for 24 weeks with periodic blood draws to determine time to recovery of hemoglobin and iron stores. A 7 ml (about 1.5 teaspoons) blood sample will be drawn at each of seven study visits over the 24 weeks to track recovery of hemoglobin and iron.

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

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
    • California
      • San Francisco, California, United States, 94118
        • Blood Centers of the Pacific
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • American Red Cross, Connecticut Region
    • Pennsylvania
      • PIttsburg, Pennsylvania, United States, 15213
        • Institute for Transfusion Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Blood Center of Wisconsin

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • potential blood donors with hemoglobin of at least 12.5 gm/dL
  • no blood donation for at least 4 months
  • successful donation of a unit of whole blood

Exclusion Criteria:

  • individuals who are taking iron supplements including multivitamins containing iron and refuse to stop do so for the 24 weeks of the study.
  • baseline ferritin >300 ug/L (to exclude individuals with hemochromatosis)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron supplements
Subjects who are randomized to receive daily iron supplements after donating blood
Dietary supplement: ferrous gluconate
daily capsule of ferrous gluconate containing 38 mg of elemental iron
No Intervention: Control
Subjects who are randomized not to receive daily iron supplements after donating blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery of hemoglobin after blood donation
Time Frame: Up to 24 weeks after blood donation
Hemoglobin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of hemoglobin to 80% of the pre-donation level.
Up to 24 weeks after blood donation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron stores
Time Frame: Up to 24 weeks after blood donation
Ferritin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of to pre-donation iron stores.
Up to 24 weeks after blood donation
Total body iron
Time Frame: 24 weeks after blood donation
Soluble transferrin receptor (sTfR) in blood will be measured 3-7 days and 24 weeks after blood donation. The ratio of sTfR to ferritin will provide a measure of total body iron at the two time points. Recovery of total body iron will be estimated from the difference between the ratios at the two time points.
24 weeks after blood donation

Collaborators and Investigators

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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

University of California, San Francisco
RTI International
Versiti
Blood Systems Research Institute
American National Red Cross
Institute for Transfusion Medicine
Blood Centers of the Pacific

Investigators

  • Principal Investigator: Joe Kiss, MD, Institute for Transfusion Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 714

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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