NCT01555060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

March 9, 2012

Last Update Submit

January 22, 2014

Conditions

Recovery of Hemoglobin and Iron Stores After Blood Donation

Keywords

hemoglobin recoveryiron recoveryiron supplements

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Iron stores

    Up to 24 weeks after blood donation

  • Total body iron

    24 weeks after blood donation

Study Arms (2)

Iron supplements

EXPERIMENTAL

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

Dietary Supplement: ferrous gluconate

Control

NO INTERVENTION

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

Interventions

ferrous gluconateDIETARY_SUPPLEMENT

daily capsule of ferrous gluconate containing 38 mg of elemental iron

Iron supplements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Blood Centers of the Pacific

San Francisco, California, 94118, United States

Location

American Red Cross, Connecticut Region

Farmington, Connecticut, 06032, United States

Location

Institute for Transfusion Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

  • 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.

    PMID: 32243609DERIVED

  • 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.

    PMID: 27232535DERIVED

  • 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.

    PMID: 25668261DERIVED

MeSH Terms

Interventions

ferrous gluconate

Study Officials

  • Joe Kiss, MD

    Institute for Transfusion Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 15, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

US(4)