Hemoglobin and Iron Recovery Study (HEIRS)

This study has been completed.
Sponsor:
Collaborators:
Institute for Transfusion Medicine
Blood Center of Wisconsin
Blood Centers of the Pacific
American Red Cross, Connecticut Region
University of California, San Francisco
Blood Systems Research Institute
RTI International
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01555060
First received: March 9, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Recovery of Hemoglobin and Iron Stores After Blood Donation
Dietary Supplement: ferrous gluconate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemoglobin and Iron Recovery Study

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Time to recovery of hemoglobin after blood donation [ Time Frame: Up to 24 weeks after blood donation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Iron stores [ Time Frame: Up to 24 weeks after blood donation ] [ Designated as safety issue: No ]
    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.

  • Total body iron [ Time Frame: 24 weeks after blood donation ] [ Designated as safety issue: No ]
    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.


Enrollment: 215
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555060

Locations
United States, California
Blood Centers of the Pacific
San Francisco, California, United States, 94118
United States, Connecticut
American Red Cross, Connecticut Region
Farmington, Connecticut, United States, 06032
United States, Pennsylvania
Institute for Transfusion Medicine
PIttsburg, Pennsylvania, United States, 15213
United States, Wisconsin
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Institute for Transfusion Medicine
Blood Center of Wisconsin
Blood Centers of the Pacific
American Red Cross, Connecticut Region
University of California, San Francisco
Blood Systems Research Institute
RTI International
Investigators
Principal Investigator: Joe Kiss, MD Institute for Transfusion Medicine
  More Information

No publications provided

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01555060     History of Changes
Other Study ID Numbers: 714
Study First Received: March 9, 2012
Last Updated: January 22, 2014
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
hemoglobin recovery
iron recovery
iron supplements

Additional relevant MeSH terms:
Ferrous gluconate
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014