Hemoglobin and Iron Recovery Study

Phase 2

Completed

• Conditions: Recovery of Hemoglobin and Iron Stores After Blood Donation
• Interventions: Dietary Supplement: ferrous gluconate

• Registration Number: NCT01555060
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron supplements	ferrous gluconate	Subjects who are randomized to receive daily iron supplements after donating blood

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Blood Centers of the Pacific; 🇺🇸 San Francisco, California, United States

American Red Cross, Connecticut Region; 🇺🇸 Farmington, Connecticut, United States

Institute for Transfusion Medicine; 🇺🇸 PIttsburg, Pennsylvania, United States

Blood Center of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States