Recovery of Hemoglobin and Iron Stores After Blood DonationPhase 2HEIRSNCT01555060
Hemoglobin and Iron Recovery Study
A Phase 2 study testing ferrous gluconate in people with Recovery of Hemoglobin and Iron Stores After Blood Donation, run by National Heart, Lung, and Blood Institute (NHLBI) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recovery of Hemoglobin and Iron Stores After Blood Donation
- What is being tested?
- ferrous gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
American Red Cross, Connecticut Region
Farmington, Connecticut, 06032
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53226
Institute for Transfusion Medicine
Pittsburgh, Pennsylvania, 15213
Blood Centers of the Pacific
San Francisco, California, 94118
About this study
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.
Read the 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.
- Being tested
- ferrous gluconate
- Keywords
- hemoglobin recovery, iron recovery, iron supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous gluconateDietary supplement
daily capsule of ferrous gluconate containing 38 mg of elemental iron
| Study group | Role | What they receive |
|---|---|---|
| Iron supplements | Experimental | Subjects who are randomized to receive daily iron supplements after donating blood Receives: Dietary Supplement: ferrous gluconate |
| Control | No intervention | Subjects who are randomized not to receive daily iron supplements after donating blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks after blood donation
Secondary outcomes (2)
Iron stores
Ferritin 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 to pre-donation iron stores.
Measured: Up to 24 weeks after blood donation
Total body iron
Soluble transferrin receptor (sTfR) in blood will be measured 3-7 days and 24 weeks after blood donation. The ratio of sTfR to ferritin will provide a measure of total body iron at the two time points. Recovery of total body iron will be estimated from the difference between the ratios at the two time points.
Measured: 24 weeks after blood donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recovery of Hemoglobin and Iron Stores After Blood DonationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Institute for Transfusion Medicine, Versiti Blood Health, Blood Centers of the Pacific, American National Red Cross, University of California, San Francisco, Vitalant Research Institute, RTI International
- Responsible party
- Sponsor
- Investigators
- Joe Kiss, MD, Principal investigator, Institute for Transfusion Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555060
- Sponsor's protocol ID
- 714
- Acronym
- HEIRS
- Status last verified
- Jan 2014
- First submitted
- 9 Mar 2012
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32243609Cable 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.
PubMed 27232535Kiss 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.
PubMed 25668261
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoglobin and Iron Recovery Study
- ClinicalTrials.gov ID
- NCT01555060
- Acronym / sponsor ID
- HEIRS / 714
- Keywords
- hemoglobin recovery, iron recovery, iron supplements
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Institute for Transfusion Medicine, Versiti Blood Health, Blood Centers of the Pacific, American National Red Cross, University of California, San Francisco, Vitalant Research Institute, RTI International
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Mar 2012 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron supplements | Experimental | Dietary Supplement: ferrous gluconateSubjects who are randomized to receive daily iron supplements after donating blood |
| Control | No intervention | –Subjects who are randomized not to receive daily iron supplements after donating blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
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 gluconatedaily capsule of ferrous gluconate containing 38 mg of elemental iron | Dietary supplement | Iron supplements |
Primary outcome
Time to recovery of hemoglobin after blood donation
Time frame: Up to 24 weeks 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.
2 secondary outcomes
Iron stores
Time frame: Up to 24 weeks after blood donation
Total body iron
Time frame: 24 weeks after blood donation
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 23 Jan 2014.
- Derived from this study: PubMed 32243609Mast 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.
- Derived from this study: PubMed 27232535Cable 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.
- Derived from this study: PubMed 25668261Kiss 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.
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.
Joe Kiss, MD principal investigator
Institute for Transfusion Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ferrous gluconate in people with Recovery of Hemoglobin and Iron Stores After Blood Donation, run by National Heart, Lung, and Blood Institute (NHLBI) 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 2 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 23 Jan 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to recovery of hemoglobin after blood donation (time frame: Up to 24 weeks after blood donation). 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 NCT01555060, which also lists 3 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 23 Jan 2014.