Hemoglobin and Iron Recovery Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hemoglobin and Iron Recovery Study

Conditions
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Recovery of Hemoglobin and Iron Stores After Blood Donation

Intervention / Treatment
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* Dietary Supplement: ferrous gluconate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery of hemoglobin 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemoglobin recovery, iron recovery, iron supplements