Clinical trial NCT01752413: Iron Depletion and Replacement in Blood Donors
Official title: Iron Depletion and Replacement in Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Iron depletion
blood donors
iron replacement
Lead sponsor: Memorial Blood Centers, Minnesota
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation
timeFrame: Two years
Secondary outcomes:
measure: Number of Participants With Improved Ferritin Levels on Subsequent Visit
timeFrame: Two years
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Memorial Blood Centers
state: Minnesota
Study officials:
affiliation: Memorial Blood Centers
name: Jed B. Gorlin, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: