CompletedNCT02245321STRIDEUpdated Dec 6, 2023

Strategies to Reduce Iron Deficiency

An interventional study of Ferrous gluconate- 19 mg and Ferrous gluconate- 38 mg in Iron Deficiency, sponsored by Westat. Completed at 4 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by Westat · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 702
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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:

Determine whether regular blood donors provided with accurate information about their iron status and written recommended courses of action will take steps to prevent/mitigate iron deficiency on their own without being given iron supplements by the blood center; and
Determine if two different amounts of iron provided by the blood center will prevent/mitigate iron deficiency in regular blood donors.

To conduct this randomized, placebo controlled study, participant donors will be assigned to one of two arms and followed for a 24 month period. Each subject will provide additional blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.

Under the two study arms, subjects are to be randomized into one of the following five blinded categories:

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).

Read the detailed description

Inclusion Criteria

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 the study for two more years, give a blood sample at each visit, and complete baseline and follow-up surveys.

Exclusion Criteria

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.

Conditions studied

Iron Deficiency

Browse trials for

Keywords

hemoglobin recovery
iron recovery
iron supplements

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 702 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Westat is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 702 participants (actual)

Study arms

Placebo comparator
Letter Group- No information
Receive a thank you letter after each blood donation.
Other: Letter - No Information Provided
Experimental
Letter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Other: Letter Group- Information Provided
Placebo comparator
Ferrous gluconate- 0 mg
Receive pills to take daily that contain no iron (a placebo or inert pill).
Dietary Supplement: Placebo
Experimental
Ferrous gluconate- 19 mg
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
Experimental
Ferrous gluconate- 38 mg
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

Dietary supplementFerrous gluconate- 19 mg
Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
Dietary supplementFerrous gluconate- 38 mg
Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
OtherLetter Group- Information Provided
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
OtherLetter - No Information Provided
Receive a letter thanking the participant for their participation.
Dietary supplementPlacebo
Receive pills to take daily that contain 0 mg iron.

What researchers measure

Primary outcomes

Hemoglobin (HgB)
a protein responsible for transporting oxygen in the blood
Time frame: Change from baseline in HgB over 2 years

Secondary outcomes

Ferritin
a protein that stores iron and releases it when your body needs it
Time frame: Change from baseline in ferritin over 2 years
Soluble transferrin receptor (sTfR)
a protein receptor that is used as a measure of functional iron status and the investigation of iron deficiency anemia
Time frame: Change from baseline in sTfR over 2 years
Laboratory Hematology results
Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)
Time frame: Change from baseline in Laboratory hematology results over 2 years.

Study locations

4 sites

American Red Cross, Connecticut Region
Farmington, Connecticut 06032, United States
Westat
Rockville, Maryland 20850, United States
The Institute for Transfusion Medicince
Pittsburgh, Pennsylvania 15220, United States
BloodCenter of Wisconsin
Milwaukee, Wisconsin 53226, United States

References and documents

Publications

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. PubMed 28494509 ↗
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. PubMed 28164344 ↗
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. PubMed 26813849 ↗
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. PubMed 25469720 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02245321
Lead sponsor: Westat
Collaborators: Versiti, American National Red Cross, The Institute for Transfusion Medicine
Responsible party: Sponsor
First posted: Sep 19, 2014
Start date: Jun 2011
Primary completion: May 2014
Completion: Jun 2014
Last update: Dec 6, 2023

Study contacts

Alan Mast, MD, PhD

principal investigator · BloodCenters of Wisconsin

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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