NCT01555060

Hemoglobin and Iron Recovery Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recovery of Hemoglobin and Iron Stores After Blood Donation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ferrous gluconate	daily capsule of ferrous gluconate containing 38 mg of elemental iron

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2012-03-15
• Last updated: 2014-01-23

Locations

4 sites across 1 country: United States