NCT02245321

Brief Summary

The prevalence of iron deficiency in blood donors has been demonstrated to be a direct consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is priority to implement programs to remediate iron deficiency issues associated with blood donations. To explore this issue, the study's aims to:

  • Receive a thank you letter after each blood donation.
  • Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
  • Receive pills to take daily that contain no iron (a placebo or inert pill).
  • Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
  • Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
702

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

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

June 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

September 10, 2014

Last Update Submit

December 4, 2023

Conditions

Iron Deficiency

Keywords

hemoglobin recoveryiron recoveryiron supplements

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin (HgB)

    a protein responsible for transporting oxygen in the blood

    Change from baseline in HgB over 2 years

Secondary Outcomes (3)

  • Ferritin

    Change from baseline in ferritin over 2 years

  • Soluble transferrin receptor (sTfR)

    Change from baseline in sTfR over 2 years

  • Laboratory Hematology results

    Change from baseline in Laboratory hematology results over 2 years.

Study Arms (5)

Letter Group- No information

PLACEBO COMPARATOR

Receive a thank you letter after each blood donation.

Other: Letter - No Information Provided

Letter Group- Information Provided

EXPERIMENTAL

Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.

Other: Letter Group- Information Provided

Ferrous gluconate- 0 mg

PLACEBO COMPARATOR

Receive pills to take daily that contain no iron (a placebo or inert pill).

Dietary Supplement: Placebo

Ferrous gluconate- 19 mg

EXPERIMENTAL

Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).

Dietary Supplement: Ferrous gluconate- 19 mg

Ferrous gluconate- 38 mg

EXPERIMENTAL

Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).

Dietary Supplement: Ferrous gluconate- 38 mg

Interventions

Ferrous gluconate- 19 mgDIETARY_SUPPLEMENT

Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).

Ferrous gluconate- 19 mg
Ferrous gluconate- 38 mgDIETARY_SUPPLEMENT

Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).

Ferrous gluconate- 38 mg
Letter Group- Information ProvidedOTHER

Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.

Letter Group- Information Provided
Letter - No Information ProvidedOTHER

Receive a letter thanking the participant for their participation.

Letter Group- No information
PlaceboDIETARY_SUPPLEMENT

Receive pills to take daily that contain 0 mg iron.

Ferrous gluconate- 0 mg

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Repeat donors who have previously participated in RISE study and have continued to donate at a required frequency (donated whole blood or double red cells ≥ 2 times in the last 12 months if female, or, ≥ 3 times in the last 12 months if male)
  • Non-RISE donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months if female, or, ≥ 3 times in the last 12 months if male
  • commitment to meet the donation frequency requirement for this study for two more years, give a blood sample at each visit, and complete baseline and follow-up surveys

You may not qualify if:

  • subjects \< 18 years of age
  • subjects taking iron supplements (including multivitamins with iron) up to one month prior to enrollment
  • females who are pregnant or plan to become pregnant in the following 2 years
  • subjects unwilling to meet the requirements of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

American Red Cross, Connecticut Region

Farmington, Connecticut, 06032, United States

Location

Westat

Rockville, Maryland, 20850, United States

Location

The Institute for Transfusion Medicince

Pittsburgh, Pennsylvania, 15220, United States

Location

BloodCenter of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (4)

  • Bialkowski W, Kiss JE, Wright DJ, Cable R, Birch R, D'Andrea P, Bryant BJ, Spencer BR, Mast AE. Estimates of total body iron indicate 19 mg and 38 mg oral iron are equivalent for the mitigation of iron deficiency in individuals experiencing repeated phlebotomy. Am J Hematol. 2017 Sep;92(9):851-857. doi: 10.1002/ajh.24784. Epub 2017 Jun 9.

    PMID: 28494509RESULT

  • Chansky MC, King MR, Bialkowski W, Bryant BJ, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Mast AE. Qualitative assessment of pica experienced by frequent blood donors. Transfusion. 2017 Apr;57(4):946-951. doi: 10.1111/trf.13981. Epub 2017 Feb 5.

    PMID: 28164344RESULT

  • Mast AE, Bialkowski W, Bryant BJ, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR. A randomized, blinded, placebo-controlled trial of education and iron supplementation for mitigation of iron deficiency in regular blood donors. Transfusion. 2016 Jun;56(6 Pt 2):1588-97. doi: 10.1111/trf.13469. Epub 2016 Jan 26.

    PMID: 26813849RESULT

  • Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3.

    PMID: 25469720RESULT

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous gluconate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alan Mast, MD, PhD

    BloodCenters of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 19, 2014

Study Start

June 1, 2011

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

US(4)