Trial record 2 of 16 for:    Open Studies | "Blood Donors"

Iron Depletion and Replacement in Blood Donors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Memorial Blood Centers, Minnesota
Sponsor:
Information provided by (Responsible Party):
Memorial Blood Centers, Minnesota
ClinicalTrials.gov Identifier:
NCT01752413
First received: December 10, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Anemia
Dietary Supplement: Ferrous gluconate 325mg
Behavioral: Nutrition counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Iron Depletion and Replacement in Blood Donors

Resource links provided by NLM:


Further study details as provided by Memorial Blood Centers, Minnesota:

Primary Outcome Measures:
  • Measure adherence to iron replacement therapy among blood donors [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Measure donor adherence to iron replacement therapy using a self-reported 5-level scale of iron intake.


Secondary Outcome Measures:
  • Determine the feasibility of blood centers to implement an iron replacement therapy program. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Track the costs of implementing an iron replacement program among blood donors, including testing ferritin, and distributing iron supplements to blood donors with low ferritin levels, and follow-up. Complete a general assessment of study staff of ease of implementing iron replacement program.


Other Outcome Measures:
  • Effect of iron replacement therapy on ferritin and hemoglobin levels [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Measure the difference of 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 baseline.


Estimated Enrollment: 1000
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: 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.
Behavioral: Nutrition counseling
All blood donors receive current dietary counseling recommending iron rich foods
Active Comparator: 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.
Behavioral: Nutrition counseling
All blood donors receive current dietary counseling recommending iron rich foods

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752413

Contacts
Contact: Kim M Doeden, MPH 651.332.7286 kdoeden@mbc.org

Locations
United States, Minnesota
Memorial Blood Centers Recruiting
St. Paul, Minnesota, United States, 55114
Contact: Kim M Doeden, MPH    651-332-7286    kdoeden@mbc.org   
Contact: Jed B Gorlin, MD, MBA    651.332.7284    jed@mbc.org   
Principal Investigator: Jed B. Gorlin, MD, MBA         
Sponsors and Collaborators
Memorial Blood Centers, Minnesota
Investigators
Principal Investigator: Jed B. Gorlin, MD, MBA Memorial Blood Centers
  More Information

No publications provided

Responsible Party: Memorial Blood Centers, Minnesota
ClinicalTrials.gov Identifier: NCT01752413     History of Changes
Other Study ID Numbers: IDAR-PN
Study First Received: December 10, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Blood Centers, Minnesota:
Iron depletion
blood donors
iron replacement

Additional relevant MeSH terms:
Iron
Ferrous gluconate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014