Recovery of Hemoglobin and Iron Stores After Blood Donation
Conditions
Keywords
hemoglobin recovery, iron recovery, iron supplements
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTferrous gluconate
daily capsule of ferrous gluconate containing 38 mg of elemental iron
Sponsors
Institute for Transfusion Medicine
Versiti Blood Health
Blood Centers of the Pacific
American National Red Cross
University of California, San Francisco
Vitalant Research Institute
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery of hemoglobin after blood donation | 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
| Measure | Time frame | Description |
|---|---|---|
| Iron stores | 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. |
| Total body iron | 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. |
Countries
United States
Outcome results
None listed