Iron Depletion and Replacement in Blood Donors

NCT01752413 | Completed Results

• 1 other identifier: IDAR-PN
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Iron depletion; blood donors; iron replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years

Secondary Outcomes (1)

• Number of Participants With Improved Ferritin Levels on Subsequent Visit

  Two years

Study Arms (2)

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.

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.

Behavioral: Nutrition counseling

Interventions

Ferrous gluconate 325mg DIETARY_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.

Ferrous gluconate 325mg

Nutrition counseling BEHAVIORAL

All blood donors receive current dietary counseling recommending iron rich foods

Ferrous gluconate 325mg; Nutrition counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fingerstick Hb value of 12.5-13.5 (males) or 12.0-13.0 (females)
• =\>18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Blood Centers, Minnesota: lead

Study Sites (1)

Memorial Blood Centers

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

ferrous gluconate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Jed B Gorlin MD, MBA
• Organization: Memorial Blood Centers

Jed.Gorlin@innovativeblood.org

651-332-7284

Study Officials

• Jed B. Gorlin, MD, MBA

  Memorial Blood Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-08

Locations

US (1)