Iron Depletion and Replacement in Blood Donors

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.

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