AnemiaNCT01752413
Iron Depletion and Replacement in Blood Donors
A study testing Ferrous gluconate 325mg and Nutrition counseling in people with Anemia, run by Memorial Blood Centers, Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Ferrous gluconate 325mg and Nutrition counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fingerstick Hb value of 12.5-13.5 (males) or 12.0-13.0 (females)
- Meets all other blood donor inclusion criteria
- =>18 years of age
Who cannot join
- History or family history of hemochromatosis, colon cancer, intestinal polyps, or chronic gastrointestinal disease
- Currently taking iron in a form other than a multivitamin
- Currently on a chronic therapeutic use of NSAIDS or anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron replacement therapy to donors.
Read the detailed description
This prospective study will be conducted under IRB approval at Memorial Blood Centers. Approximately 1000 donors will be enrolled over a two-year period.
Participant Recruitment Donors presenting to donate whole blood at MBC who have a Hb value between 12.5-13.5 (males) or 12.0-13.0 (females) will be asked to participate. Written informed consent will be obtained from each participant.
STUDY PROCEDURES MBC will be responsible for donor consenting, specimen collection and testing, donor deferral, donor-follow-up, and record keeping. Before any study participation, donors who meet the inclusion criteria will be required to sign and date an informed consent. All participants will receive a study information sheet and be asked screening questions and donor information.
An EDTA and red top tube will be taken from the diversion pouch of each participant during their donation, or obtained from samples already drawn for donor screening. The EDTA sample and red top tube will be used to determine baseline CBC and ferritin levels, respectively.
Female participants who have a Hb of 12.0-12.4 will not be allowed to donate per FDA regulations, but will be asked to have an EDTA and red top tube drawn to determine baseline CBC and ferritin levels, respectively.
Participants whose ferritin levels are <30 (males) or <20 (females) will be eligible for enrollment into the low ferritin group. Those with ferritin levels >30 (males) or >20 (females) will be enrolled into the low Hb only group. Females whose Hb was in the range of 12.0-12.4 and with ferritin levels >20 will not be followed.
Once ferritin levels are determined, participants in both groups will be contacted by a study nurse. Those in the low Hb only group will be notified of their results and allowed to return after a standard 56 day deferral. Those in the low ferritin group will be offered iron replacement therapy and deferred from blood donation for 112 days.
Oral Iron Replacement Therapy Participants in the low ferritin group will be offered 200 tablets of Ferrous gluconate 325 mg (36 mg elemental iron) sent by mail. Tablets will be in child proof containers. This amount and form of iron were chosen because of its ready accessibility over the counter in packs of 100 at low cost to donor/donor center. Also, the following anemia website suggests 60mg elemental iron daily, i.e. 2-3 iron tablets in divided doses daily.Participants will be instructed to take one at lunch and one at bedtime. Participants will be instructed to contact the study physician or study nurse immediately if any adverse events occur.
Between 25 and 35 days, the study physician or nurse will contact all participants in the low ferritin group to assess their compliance and tolerance with the iron replacement therapy using a standard instrument. Those with unacceptable intolerance to the ferrous gluconate may be offered carbonyl iron at this time, and re-interviewed between days 60 and 70 using the same instrument.
Participant Follow-Up Participants in both groups will be asked to return to donate after their deferral period. During their follow-up donation, participants will be asked to complete a follow-up questionnaire, and samples will again be taken to determine CBC and ferritin levels. Participants will be notified of their results. Statistical analysis will be performed to determine outcome measures.
- Conditions
- Anemia
- Being tested
- Ferrous gluconate 325mg, Nutrition counseling
- Keywords
- Iron depletion, blood donors, iron replacement
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous gluconate 325mgDietary supplement
Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.
Nutrition counselingBehavioural
All blood donors receive current dietary counseling recommending iron rich foods
| Study group | Role | What they receive |
|---|---|---|
| Ferrous gluconate 325mg | Experimental | Those found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling. Receives: Dietary Supplement: Ferrous gluconate 325mg; Behavioral: Nutrition counseling |
| Nutrition counseling | Active comparator | For those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation. Receives: Behavioral: Nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation
Subject self reported habits for taking iron supplement or iron rich diet and severity of gastrointestinal complaints (minimal-1 to severe-5). GI complaints were not separated by type for analysis.
Measured: Two years
Secondary outcomes (1)
Number of Participants With Improved Ferritin Levels on Subsequent Visit
Compared ferritin levels at baseline and after iron replacement therapy among blood donors, adjusting for time between visits, participant adherence levels, and whether a unit was donated at second visit.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Blood Centers, Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jed B. Gorlin, MD, MBA, Principal investigator, Memorial Blood Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752413
- Sponsor's protocol ID
- IDAR-PN
- Status last verified
- Aug 2021
- First submitted
- 10 Dec 2012
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Depletion and Replacement in Blood Donors
- ClinicalTrials.gov ID
- NCT01752413
- Acronym / sponsor ID
- IDAR-PN
- Conditions
- Anemia
- Keywords
- Iron depletion, blood donors, iron replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Memorial Blood Centers, MinnesotaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Posted 28 Sep 2021
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 determine (1) the role of ferritin testing to screen for iron depletion in donors at risk of low iron levels (2) the effectiveness of oral iron replacement therapy on the repletion of iron stores in donors, and (3) the feasibility of blood centers to routinely distribute oral iron replacement therapy to donors.
Detailed description
This prospective study will be conducted under IRB approval at Memorial Blood Centers. Approximately 1000 donors will be enrolled over a two-year period.
Participant Recruitment Donors presenting to donate whole blood at MBC who have a Hb value between 12.5-13.5 (males) or 12.0-13.0 (females) will be asked to participate. Written informed consent will be obtained from each participant.
STUDY PROCEDURES MBC will be responsible for donor consenting, specimen collection and testing, donor deferral, donor-follow-up, and record keeping. Before any study participation, donors who meet the inclusion criteria will be required to sign and date an informed consent. All participants will receive a study information sheet and be asked screening questions and donor information.
An EDTA and red top tube will be taken from the diversion pouch of each participant during their donation, or obtained from samples already drawn for donor screening. The EDTA sample and red top tube will be used to determine baseline CBC and ferritin levels, respectively.
Female participants who have a Hb of 12.0-12.4 will not be allowed to donate per FDA regulations, but will be asked to have an EDTA and red top tube drawn to determine baseline CBC and ferritin levels, respectively.
Participants whose ferritin levels are <30 (males) or <20 (females) will be eligible for enrollment into the low ferritin group. Those with ferritin levels >30 (males) or >20 (females) will be enrolled into the low Hb only group. Females whose Hb was in the range of 12.0-12.4 and with ferritin levels >20 will not be followed.
Once ferritin levels are determined, participants in both groups will be contacted by a study nurse. Those in the low Hb only group will be notified of their results and allowed to return after a standard 56 day deferral. Those in the low ferritin group will be offered iron replacement therapy and deferred from blood donation for 112 days.
Oral Iron Replacement Therapy Participants in the low ferritin group will be offered 200 tablets of Ferrous gluconate 325 mg (36 mg elemental iron) sent by mail. Tablets will be in child proof containers. This amount and form of iron were chosen because of its ready accessibility over the counter in packs of 100 at low cost to donor/donor center. Also, the following anemia website suggests 60mg elemental iron daily, i.e. 2-3 iron tablets in divided doses daily.Participants will be instructed to take one at lunch and one at bedtime. Participants will be instructed to contact the study physician or study nurse immediately if any adverse events occur.
Between 25 and 35 days, the study physician or nurse will contact all participants in the low ferritin group to assess their compliance and tolerance with the iron replacement therapy using a standard instrument. Those with unacceptable intolerance to the ferrous gluconate may be offered carbonyl iron at this time, and re-interviewed between days 60 and 70 using the same instrument.
Participant Follow-Up Participants in both groups will be asked to return to donate after their deferral period. During their follow-up donation, participants will be asked to complete a follow-up questionnaire, and samples will again be taken to determine CBC and ferritin levels. Participants will be notified of their results. Statistical analysis will be performed to determine outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous gluconate 325mg | Experimental | Dietary Supplement: Ferrous gluconate 325mg, Behavioral: Nutrition counselingThose found iron depleted by ferritin measure will receive 325 mg Ferrous gluconate twice a day for 100 days. They will be deferred as a whole blood donor for 120 days until completion of iron therapy. They will receive standard dietary counseling. |
| Nutrition counseling | Active comparator | Behavioral: Nutrition counselingFor those consenting to this study but who demonstrate adequate ferritin levels (>20 micrograms/L female, >30 micrograms/L males), they will not receive oral iron or additional deferral period but will be allowed to donate after the standard 56 days. They will receive standard counseling about iron rich foods. Rate and frequency of subsequent donations will be tracked and compared to those receiving iron supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fingerstick Hb value of 12.5-13.5 (males) or 12.0-13.0 (females)
- Meets all other blood donor inclusion criteria
- =>18 years of age
Key exclusion criteria (3 listed)
- History or family history of hemochromatosis, colon cancer, intestinal polyps, or chronic gastrointestinal disease
- Currently taking iron in a form other than a multivitamin
- Currently on a chronic therapeutic use of NSAIDS or anticoagulants
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 325mgParticipants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day. | Dietary supplement | Ferrous gluconate 325mg |
| Nutrition counselingAll blood donors receive current dietary counseling recommending iron rich foods | Behavioural | Ferrous gluconate 325mg, Nutrition counseling |
Primary outcome
Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation
Time frame: Two years
Subject self reported habits for taking iron supplement or iron rich diet and severity of gastrointestinal complaints (minimal-1 to severe-5). GI complaints were not separated by type for analysis.
1 secondary outcome
Number of Participants With Improved Ferritin Levels on Subsequent Visit
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jed B. Gorlin, MD, MBA principal investigator
Memorial Blood Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous gluconate 325mg and Nutrition counseling in people with Anemia, run by Memorial Blood Centers, Minnesota at 1 site 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 3 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.