Anemia
Conditions
Keywords
Iron depletion, blood donors, iron replacement
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTFerrous gluconate 325mg
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.
BEHAVIORALNutrition counseling
All blood donors receive current dietary counseling recommending iron rich foods
Sponsors
Memorial Blood Centers, Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improved Ferritin Levels on Subsequent Visit | Two years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferrous Gluconate 325mg 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.
Ferrous gluconate 325mg: 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 counseling: All blood donors receive current dietary counseling recommending iron rich foods | 170 |
| Nutrition Counseling 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.
Nutrition counseling: All blood donors receive current dietary counseling recommending iron rich foods | 27 |
| Total | 197 |
Baseline characteristics
| Characteristic | Ferrous Gluconate 325mg | Nutrition Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 41 Participants | 4 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 128 Participants | 23 Participants | 151 Participants |
| Region of Enrollment United States | 170 participants | 27 participants | 197 participants |
| Sex: Female, Male Female | 130 Participants | 17 Participants | 147 Participants |
| Sex: Female, Male Male | 40 Participants | 10 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 170 | 0 / 27 |
| other Total, other adverse events | 35 / 170 | 6 / 27 |
| serious Total, serious adverse events | 0 / 170 | 0 / 27 |
Outcome results
Primary
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.
Time frame: Two years
Population: Repeat Blood Donors
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferrous Gluconate 325mg | Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation | 116 Participants |
| Nutrition Counseling | Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation | 17 Participants |
Secondary
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.
Time frame: Two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferrous Gluconate 325mg | Number of Participants With Improved Ferritin Levels on Subsequent Visit | 73 Participants |
| Nutrition Counseling | Number of Participants With Improved Ferritin Levels on Subsequent Visit | 6 Participants |