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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

March 9, 2012
January 22, 2014
March 2012
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01555060 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Hemoglobin and Iron Recovery Study
Hemoglobin and Iron Recovery Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Recovery of Hemoglobin and Iron Stores After Blood Donation
Dietary Supplement: ferrous gluconate
daily capsule of ferrous gluconate containing 38 mg of elemental iron
  • Experimental: Iron supplements
    Subjects who are randomized to receive daily iron supplements after donating blood
    Intervention: Dietary Supplement: ferrous gluconate
  • No Intervention: Control
    Subjects who are randomized not to receive daily iron supplements after donating blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
June 2013
May 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01555060
714
Yes
National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
  • 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
Principal Investigator: Joe Kiss, MD Institute for Transfusion Medicine
National Heart, Lung, and Blood Institute (NHLBI)
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP