Hemoglobin and Iron Recovery Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

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.

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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.

Conditions

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Recovery of Hemoglobin and Iron Stores After Blood Donation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron supplements

Subjects who are randomized to receive daily iron supplements after donating blood

Group Type EXPERIMENTAL

ferrous gluconate

Intervention Type DIETARY_SUPPLEMENT

daily capsule of ferrous gluconate containing 38 mg of elemental iron

Control

Subjects who are randomized not to receive daily iron supplements after donating blood

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ferrous gluconate

daily capsule of ferrous gluconate containing 38 mg of elemental iron

Intervention Type DIETARY_SUPPLEMENT

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No