Trial Outcomes & Findings for Iron Depletion and Replacement in Blood Donors (NCT NCT01752413)

NCT ID: NCT01752413

Last Updated: 2021-09-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 197 participants
• Primary outcome timeframe: Two years
• Results posted on: 2021-09-28

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	170	27
Overall Study COMPLETED	58	6
Overall Study NOT COMPLETED	112	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iron Depletion and Replacement in Blood Donors

Baseline characteristics by cohort

Measure	Ferrous Gluconate 325mg n=170 Participants 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	Nutrition Counseling n=27 Participants 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	Total n=197 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	128 Participants n=5 Participants	23 Participants n=7 Participants	151 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants	4 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	17 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	10 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	170 participants n=5 Participants	27 participants n=7 Participants	197 participants n=5 Participants

PRIMARY outcome

Timeframe: Two years

Population: Repeat Blood Donors

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.

Outcome measures

Measure	Ferrous Gluconate 325mg n=170 Participants 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	Nutrition Counseling n=27 Participants 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
Number of Participants With Adherence to Iron Replacement Therapy at Subsequent Donation	116 Participants	17 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ferrous Gluconate 325mg n=116 Participants 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	Nutrition Counseling n=17 Participants 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
Number of Participants With Improved Ferritin Levels on Subsequent Visit	73 Participants	6 Participants

Adverse Events

Ferrous Gluconate 325mg

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Nutrition Counseling

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ferrous Gluconate 325mg n=170 participants at risk 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	Nutrition Counseling n=27 participants at risk 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
Gastrointestinal disorders GI complaints	20.6% 35/170 • Number of events 35 • Two Years post initial donation Gastrointestinal complaints self reported by subject on a scale of 1 for Minimal to 5 for Severe. Complaints grouped for analysis.	22.2% 6/27 • Number of events 6 • Two Years post initial donation Gastrointestinal complaints self reported by subject on a scale of 1 for Minimal to 5 for Severe. Complaints grouped for analysis.

Additional Information

Jed B Gorlin MD, MBA

Memorial Blood Centers

Phone: 651-332-7284

Email: Jed.Gorlin@innovativeblood.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place