Iron DeficiencySTRIDENCT02245321
Strategies to Reduce Iron Deficiency
A study testing Ferrous gluconate- 19 mg, Ferrous gluconate- 38 mg and Letter Group- Information Provided in people with Iron Deficiency, run by Westat at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Ferrous gluconate- 19 mg, Ferrous gluconate- 38 mg and Letter Group- Information Provided
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 702 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
American Red Cross, Connecticut Region
Farmington, Connecticut, 06032
BloodCenter of Wisconsin
Milwaukee, Wisconsin, 53226
The Institute for Transfusion Medicince
Pittsburgh, Pennsylvania, 15220
Westat
Rockville, Maryland, 20850
About this study
Official title: Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors
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.
Read more
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
- Iron Deficiency
- Being tested
- Ferrous gluconate- 19 mg, Ferrous gluconate- 38 mg, Letter Group- Information Provided, Letter - No Information Provided, Placebo
- Keywords
- hemoglobin recovery, iron recovery, iron supplements
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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- 38 mgDietary supplement
Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
Letter Group- Information ProvidedOther
Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
Letter - No Information ProvidedOther
Receive a letter thanking the participant for their participation.
PlaceboDietary supplement
Receive pills to take daily that contain 0 mg iron.
| Study group | Role | What they receive |
|---|---|---|
| Letter Group- No information | Placebo comparator | Receive a thank you letter after each blood donation. Receives: 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. Receives: 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). Receives: 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). Receives: 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). Receives: Dietary Supplement: Ferrous gluconate- 38 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (HgB)
a protein responsible for transporting oxygen in the blood
Measured: Change from baseline in HgB over 2 years
Secondary outcomes (3)
Ferritin
a protein that stores iron and releases it when your body needs it
Measured: 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
Measured: Change from baseline in sTfR over 2 years
Laboratory Hematology results
Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH)
Measured: Change from baseline in Laboratory hematology results over 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJun 2011
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westat
- Sponsor type
- University, hospital or other
- Collaborators
- Versiti Blood Health, American National Red Cross, The Institute for Transfusion Medicine
- Responsible party
- Sponsor
- Investigators
- Alan Mast, MD, PhD, Principal investigator, BloodCenters of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245321
- Sponsor's protocol ID
- 1R01HL10580901
- Acronym
- STRIDE
- Status last verified
- Dec 2023
- First submitted
- 10 Sep 2014
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
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 28494509Chansky 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 28164344Mast 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 26813849Bialkowski 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors
- ClinicalTrials.gov ID
- NCT02245321
- Acronym / sponsor ID
- STRIDE / 1R01HL10580901
- Conditions
- Iron Deficiency
- Keywords
- hemoglobin recovery, iron recovery, iron supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- WestatUniversity, hospital or other
- Collaborators
- Versiti Blood Health, American National Red Cross, The Institute for Transfusion Medicine
- Study start
- Jun 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Letter Group- No information | Placebo comparator | Other: Letter - No Information ProvidedReceive a thank you letter after each blood donation. |
| Letter Group- Information Provided | Experimental | Other: Letter Group- Information ProvidedReceive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. |
| Ferrous gluconate- 0 mg | Placebo comparator | Dietary Supplement: PlaceboReceive pills to take daily that contain no iron (a placebo or inert pill). |
| Ferrous gluconate- 19 mg | Experimental | Dietary Supplement: Ferrous gluconate- 19 mgReceive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron). |
| Ferrous gluconate- 38 mg | Experimental | Dietary Supplement: Ferrous gluconate- 38 mgReceive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous gluconate- 19 mgReceive 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 mgReceive 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 |
| Letter Group- Information ProvidedReceive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. | Other | Letter Group- Information Provided |
| Letter - No Information ProvidedReceive a letter thanking the participant for their participation. | Other | Letter Group- No information |
| PlaceboReceive pills to take daily that contain 0 mg iron. | Dietary supplement | Ferrous gluconate- 0 mg |
Primary outcome
Hemoglobin (HgB)
Time frame: Change from baseline in HgB over 2 years
a protein responsible for transporting oxygen in the blood
3 secondary outcomes
Ferritin
Time frame: Change from baseline in ferritin over 2 years
Soluble transferrin receptor (sTfR)
Time frame: Change from baseline in sTfR over 2 years
Laboratory Hematology results
Time frame: Change from baseline in Laboratory hematology results over 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 28494509Bialkowski 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.
- Results publication: PubMed 28164344Chansky 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.
- Results publication: PubMed 26813849Mast 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.
- Results publication: PubMed 25469720Bialkowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Mast, MD, PhD principal investigator
BloodCenters of Wisconsin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous gluconate- 19 mg, Ferrous gluconate- 38 mg and Letter Group- Information Provided in people with Iron Deficiency, run by Westat at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (HgB) (time frame: Change from baseline in HgB over 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245321, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.