Clinical trial NCT01555060: Hemoglobin and Iron Recovery Study
Official title: Hemoglobin and Iron Recovery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recovery of Hemoglobin and Iron Stores After Blood Donation
Keywords: hemoglobin recovery
iron recovery
iron supplements
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: Institute for Transfusion Medicine
name: Versiti
name: Blood Centers of the Pacific
name: American National Red Cross
name: University of California, San Francisco
name: Vitalant Research Institute
name: RTI International
First posted: 2012-03-15
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time to recovery of hemoglobin after blood donation
timeFrame: Up to 24 weeks after blood donation
Secondary outcomes:
measure: Iron stores
timeFrame: Up to 24 weeks after blood donation
measure: Total body iron
timeFrame: 24 weeks after blood donation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Blood Centers of the Pacific
state: California
city: Farmington
country: United States
facility: American Red Cross, Connecticut Region
state: Connecticut
city: PIttsburg
country: United States
facility: Institute for Transfusion Medicine
state: Pennsylvania
city: Milwaukee
country: United States
facility: Blood Center of Wisconsin
state: Wisconsin
Study officials:
affiliation: Institute for Transfusion Medicine
name: Joe Kiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mast AE, Szabo A, Stone M, Cable RG, Spencer BR, Kiss JE; NHLBI Recipient Epidemiology Donor Evaluation Study (REDS)-III. The benefits of iron supplementation following blood donation vary with baseline iron status. Am J Hematol. 2020 Jul;95(7):784-791. doi: 10.1002/ajh.25800. Epub 2020 Apr 15.
citation: Cable RG, Brambilla D, Glynn SA, Kleinman S, Mast AE, Spencer BR, Stone M, Kiss JE; National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Effect of iron supplementation on iron stores and total body iron after whole blood donation. Transfusion. 2016 Aug;56(8):2005-12. doi: 10.1111/trf.13659. Epub 2016 May 27.
citation: Kiss JE, Brambilla D, Glynn SA, Mast AE, Spencer BR, Stone M, Kleinman SH, Cable RG; National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Oral iron supplementation after blood donation: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):575-83. doi: 10.1001/jama.2015.119.