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Completed

NCT Number: NCT01555060

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blood Centers of the Pacific, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ferrous gluconate

Dietary Supplement

daily capsule of ferrous gluconate containing 38 mg of elemental iron

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Collaborators

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

Registry information

Acronym: HEIRS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2012
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.