Interventions can treat, prevent iron deficiency in blood donors

Blood donation in progress

ANAHEIM, CA—Data from the STRIDE study have revealed interventions that can mitigate iron deficiency in repeat blood donors.

The study showed that providing repeat blood donors with iron supplements significantly improved their iron status.

But informing donors about their ferritin levels and recommending they take iron pills also significantly improved their iron status.

Meanwhile, patients in control groups became more iron-deficient over the study period.

The study also revealed no difference in ferritin or hemoglobin levels between patients who took 19 mg of iron and those who took 38 mg.

Alan E. Mast, MD, PhD, of the Blood Center of Wisconsin in Milwaukee, presented these results at the 2015 AABB Annual Meeting (abstract S34-030E).

Dr Mast said blood donation removes a lot of iron, and iron is used to make hemoglobin in new red blood cells. But the measurement of hemoglobin does not accurately reflect iron stores.

“That’s really important,” he said. “The only test we do to qualify a blood donor doesn’t tell us if they have iron deficiency or not. And because of that, many regular blood donors become iron-deficient and continue to donate blood.”

Dr Mast said the strategies that appear to mitigate iron deficiency in regular blood donors are oral iron supplements and delaying the donation interval for more than 6 months.

“[However,] the effectiveness of providing iron pills versus providing the donor with information about their iron status has not been previously examined,” he noted.

This was the goal of the STRIDE (Strategies to Reduce Iron Deficiency) study.

Study design

This blinded, randomized, placebo-controlled study enrolled 692 frequent blood donors from 3 blood centers. They were assigned to 1 of 5 arms for 2 years of follow-up.

In 3 arms, donors received pills for 60 days after each donation. They received 38 mg or 19 mg of elemental iron, or they received a placebo.

Donors in the remaining 2 arms received letters after each donation—either a letter informing them of their iron status or a “control” letter thanking them for donating blood and urging them to donate again.

Every iron status letter reported the donor’s ferritin level. If the level was >26 mg/L, the letter simply urged donors to donate again. If the ferritin level was ≤26 mg/L, the letter recommended taking a self-purchased iron supplement (17 mg to 38 mg) and/or delaying donation for 6 months. Donors were allowed to choose either option, both, or neither.

The researchers measured ferritin, soluble transferrin receptor, and complete blood count at each donation.

Study completion

Of the 692 subjects randomized, 393 completed a final visit. The researchers noted that a donor’s ferritin level at enrollment, race, or gender did not impact study completion. However, older subjects were more likely to complete the study.

In all, 116 subjects were lost to follow-up, and the numbers were similar between the study arms. Thirty-nine subjects discontinued due to adverse events—16 in the 38 mg iron group, 12 in the 19 mg iron group, and 11 in the placebo group.

And 144 subjects discontinued for “other reasons”—9 in the iron status letter arm, 10 in the control letter arm, 30 in the 38 mg iron arm, 42 in the 19 mg iron arm, and 53 in the placebo arm.

Subjects’ reasons for discontinuation included not wanting to take a pill every day, believing they are in the placebo group and wanting to take iron, and subjects’ physicians recommending they start taking iron.

“Donors in pill arms de-enrolled more frequently than those in the letter arms, and the important thing to remember is that this is a controlled, randomized study where the donors did not know what they were taking,” Dr Mast said. “And I think that, a lot of the time, if donors had known what they were taking, they might have continued to participate in the study or continued to take the pills.”

Results

Dr Mast noted that, at the study’s end, all measures of iron deficiency were statistically indistinguishable in the 3 intervention arms, which were statistically different from the 2 control arms.

Between study enrollment and the donors’ final visit, the prevalence of ferritin <26 mg/L was unchanged in the control groups. But it had declined by more than 50% in the 3 intervention groups—19 mg iron, 38 mg iron, and iron status letter (P<0.0001 for all 3).

The prevalence of ferritin <12 mg/L was unchanged in the 2 control arms, but it had declined by more than 70% in the 3 intervention arms—19 mg iron (P<0.0001), 38 mg iron (P<0.01), and iron status letter (P<0.0001).

The researchers also calculated the odds ratios for iron deficiency over all donor visits. The odds for ferritin <26 or <12 mg/L decreased more than 80% in the 19 mg iron group (P<0.01 for both ferritin measurements) and the 38 mg iron group (P<0.01 for both).

The odds for ferritin <26 or <12 mg/L decreased about 50% in the iron status letter arm (P<0.01 for both).

And the odds for ferritin <12 mg/L increased about 50% in the control groups (P<0.01 for both the placebo and control letter groups). However, there was no significant difference for ferritin <26 mg/L in either control group.

Lastly, the researchers performed longitudinal modeling of hemoglobin. They found that hemoglobin increased >0.03 g/dL in the 19 mg and 38 mg iron arms (P<0.01 for both), decreasing the odds for low hemoglobin deferral about 50%.

Hemoglobin decreased >0.3 g/dL in the control groups (P<0.0001 for both the placebo and control letter groups), increasing the odds for low hemoglobin deferral about 70%.

“Interestingly, [being] in the iron status letter group did not affect hemoglobin that much in the longitudinal modeling of the donors,” Dr Mast noted.

In closing, he pointed out that the 19 mg and 38 mg iron pills were equally effective for mitigating iron deficiency and improving hemoglobin in these blood donors.

“From a physiology point of view, I think this is one of the most important results of this study,” Dr Mast said. “There’s absolutely no difference. There was no trend for 38 mg to be better than 19 in any analysis that we did.”

“There’s lots of reasons that could be happening, but I think it’s scientifically interesting and operationally interesting. And it’s important because we can tell donors—ask them to take a multivitamin with 19 mg of iron, and that will be sufficient to treat iron deficiency.”

Blood donation in progress

ANAHEIM, CA—Data from the STRIDE study have revealed interventions that can mitigate iron deficiency in repeat blood donors.

The study showed that providing repeat blood donors with iron supplements significantly improved their iron status.

But informing donors about their ferritin levels and recommending they take iron pills also significantly improved their iron status.

Meanwhile, patients in control groups became more iron-deficient over the study period.

The study also revealed no difference in ferritin or hemoglobin levels between patients who took 19 mg of iron and those who took 38 mg.

Alan E. Mast, MD, PhD, of the Blood Center of Wisconsin in Milwaukee, presented these results at the 2015 AABB Annual Meeting (abstract S34-030E).

Dr Mast said blood donation removes a lot of iron, and iron is used to make hemoglobin in new red blood cells. But the measurement of hemoglobin does not accurately reflect iron stores.

“That’s really important,” he said. “The only test we do to qualify a blood donor doesn’t tell us if they have iron deficiency or not. And because of that, many regular blood donors become iron-deficient and continue to donate blood.”

Dr Mast said the strategies that appear to mitigate iron deficiency in regular blood donors are oral iron supplements and delaying the donation interval for more than 6 months.

“[However,] the effectiveness of providing iron pills versus providing the donor with information about their iron status has not been previously examined,” he noted.

This was the goal of the STRIDE (Strategies to Reduce Iron Deficiency) study.

Study design

This blinded, randomized, placebo-controlled study enrolled 692 frequent blood donors from 3 blood centers. They were assigned to 1 of 5 arms for 2 years of follow-up.

In 3 arms, donors received pills for 60 days after each donation. They received 38 mg or 19 mg of elemental iron, or they received a placebo.

Donors in the remaining 2 arms received letters after each donation—either a letter informing them of their iron status or a “control” letter thanking them for donating blood and urging them to donate again.

Every iron status letter reported the donor’s ferritin level. If the level was >26 mg/L, the letter simply urged donors to donate again. If the ferritin level was ≤26 mg/L, the letter recommended taking a self-purchased iron supplement (17 mg to 38 mg) and/or delaying donation for 6 months. Donors were allowed to choose either option, both, or neither.

The researchers measured ferritin, soluble transferrin receptor, and complete blood count at each donation.

Study completion

Of the 692 subjects randomized, 393 completed a final visit. The researchers noted that a donor’s ferritin level at enrollment, race, or gender did not impact study completion. However, older subjects were more likely to complete the study.

In all, 116 subjects were lost to follow-up, and the numbers were similar between the study arms. Thirty-nine subjects discontinued due to adverse events—16 in the 38 mg iron group, 12 in the 19 mg iron group, and 11 in the placebo group.

And 144 subjects discontinued for “other reasons”—9 in the iron status letter arm, 10 in the control letter arm, 30 in the 38 mg iron arm, 42 in the 19 mg iron arm, and 53 in the placebo arm.

Subjects’ reasons for discontinuation included not wanting to take a pill every day, believing they are in the placebo group and wanting to take iron, and subjects’ physicians recommending they start taking iron.

“Donors in pill arms de-enrolled more frequently than those in the letter arms, and the important thing to remember is that this is a controlled, randomized study where the donors did not know what they were taking,” Dr Mast said. “And I think that, a lot of the time, if donors had known what they were taking, they might have continued to participate in the study or continued to take the pills.”

Results

Dr Mast noted that, at the study’s end, all measures of iron deficiency were statistically indistinguishable in the 3 intervention arms, which were statistically different from the 2 control arms.

Between study enrollment and the donors’ final visit, the prevalence of ferritin <26 mg/L was unchanged in the control groups. But it had declined by more than 50% in the 3 intervention groups—19 mg iron, 38 mg iron, and iron status letter (P<0.0001 for all 3).

The prevalence of ferritin <12 mg/L was unchanged in the 2 control arms, but it had declined by more than 70% in the 3 intervention arms—19 mg iron (P<0.0001), 38 mg iron (P<0.01), and iron status letter (P<0.0001).

The researchers also calculated the odds ratios for iron deficiency over all donor visits. The odds for ferritin <26 or <12 mg/L decreased more than 80% in the 19 mg iron group (P<0.01 for both ferritin measurements) and the 38 mg iron group (P<0.01 for both).

The odds for ferritin <26 or <12 mg/L decreased about 50% in the iron status letter arm (P<0.01 for both).

And the odds for ferritin <12 mg/L increased about 50% in the control groups (P<0.01 for both the placebo and control letter groups). However, there was no significant difference for ferritin <26 mg/L in either control group.

Lastly, the researchers performed longitudinal modeling of hemoglobin. They found that hemoglobin increased >0.03 g/dL in the 19 mg and 38 mg iron arms (P<0.01 for both), decreasing the odds for low hemoglobin deferral about 50%.

Hemoglobin decreased >0.3 g/dL in the control groups (P<0.0001 for both the placebo and control letter groups), increasing the odds for low hemoglobin deferral about 70%.

“Interestingly, [being] in the iron status letter group did not affect hemoglobin that much in the longitudinal modeling of the donors,” Dr Mast noted.

In closing, he pointed out that the 19 mg and 38 mg iron pills were equally effective for mitigating iron deficiency and improving hemoglobin in these blood donors.

“From a physiology point of view, I think this is one of the most important results of this study,” Dr Mast said. “There’s absolutely no difference. There was no trend for 38 mg to be better than 19 in any analysis that we did.”

“There’s lots of reasons that could be happening, but I think it’s scientifically interesting and operationally interesting. And it’s important because we can tell donors—ask them to take a multivitamin with 19 mg of iron, and that will be sufficient to treat iron deficiency.”

Blood donation in progress

ANAHEIM, CA—Data from the STRIDE study have revealed interventions that can mitigate iron deficiency in repeat blood donors.

The study showed that providing repeat blood donors with iron supplements significantly improved their iron status.

But informing donors about their ferritin levels and recommending they take iron pills also significantly improved their iron status.

Meanwhile, patients in control groups became more iron-deficient over the study period.

The study also revealed no difference in ferritin or hemoglobin levels between patients who took 19 mg of iron and those who took 38 mg.

Alan E. Mast, MD, PhD, of the Blood Center of Wisconsin in Milwaukee, presented these results at the 2015 AABB Annual Meeting (abstract S34-030E).

Dr Mast said blood donation removes a lot of iron, and iron is used to make hemoglobin in new red blood cells. But the measurement of hemoglobin does not accurately reflect iron stores.

“That’s really important,” he said. “The only test we do to qualify a blood donor doesn’t tell us if they have iron deficiency or not. And because of that, many regular blood donors become iron-deficient and continue to donate blood.”

Dr Mast said the strategies that appear to mitigate iron deficiency in regular blood donors are oral iron supplements and delaying the donation interval for more than 6 months.

“[However,] the effectiveness of providing iron pills versus providing the donor with information about their iron status has not been previously examined,” he noted.

This was the goal of the STRIDE (Strategies to Reduce Iron Deficiency) study.

Study design

This blinded, randomized, placebo-controlled study enrolled 692 frequent blood donors from 3 blood centers. They were assigned to 1 of 5 arms for 2 years of follow-up.

In 3 arms, donors received pills for 60 days after each donation. They received 38 mg or 19 mg of elemental iron, or they received a placebo.

Donors in the remaining 2 arms received letters after each donation—either a letter informing them of their iron status or a “control” letter thanking them for donating blood and urging them to donate again.

Every iron status letter reported the donor’s ferritin level. If the level was >26 mg/L, the letter simply urged donors to donate again. If the ferritin level was ≤26 mg/L, the letter recommended taking a self-purchased iron supplement (17 mg to 38 mg) and/or delaying donation for 6 months. Donors were allowed to choose either option, both, or neither.

The researchers measured ferritin, soluble transferrin receptor, and complete blood count at each donation.

Study completion

Of the 692 subjects randomized, 393 completed a final visit. The researchers noted that a donor’s ferritin level at enrollment, race, or gender did not impact study completion. However, older subjects were more likely to complete the study.

In all, 116 subjects were lost to follow-up, and the numbers were similar between the study arms. Thirty-nine subjects discontinued due to adverse events—16 in the 38 mg iron group, 12 in the 19 mg iron group, and 11 in the placebo group.

And 144 subjects discontinued for “other reasons”—9 in the iron status letter arm, 10 in the control letter arm, 30 in the 38 mg iron arm, 42 in the 19 mg iron arm, and 53 in the placebo arm.

Subjects’ reasons for discontinuation included not wanting to take a pill every day, believing they are in the placebo group and wanting to take iron, and subjects’ physicians recommending they start taking iron.

“Donors in pill arms de-enrolled more frequently than those in the letter arms, and the important thing to remember is that this is a controlled, randomized study where the donors did not know what they were taking,” Dr Mast said. “And I think that, a lot of the time, if donors had known what they were taking, they might have continued to participate in the study or continued to take the pills.”

Results

Dr Mast noted that, at the study’s end, all measures of iron deficiency were statistically indistinguishable in the 3 intervention arms, which were statistically different from the 2 control arms.

Between study enrollment and the donors’ final visit, the prevalence of ferritin <26 mg/L was unchanged in the control groups. But it had declined by more than 50% in the 3 intervention groups—19 mg iron, 38 mg iron, and iron status letter (P<0.0001 for all 3).

The prevalence of ferritin <12 mg/L was unchanged in the 2 control arms, but it had declined by more than 70% in the 3 intervention arms—19 mg iron (P<0.0001), 38 mg iron (P<0.01), and iron status letter (P<0.0001).

The researchers also calculated the odds ratios for iron deficiency over all donor visits. The odds for ferritin <26 or <12 mg/L decreased more than 80% in the 19 mg iron group (P<0.01 for both ferritin measurements) and the 38 mg iron group (P<0.01 for both).

The odds for ferritin <26 or <12 mg/L decreased about 50% in the iron status letter arm (P<0.01 for both).

And the odds for ferritin <12 mg/L increased about 50% in the control groups (P<0.01 for both the placebo and control letter groups). However, there was no significant difference for ferritin <26 mg/L in either control group.

Lastly, the researchers performed longitudinal modeling of hemoglobin. They found that hemoglobin increased >0.03 g/dL in the 19 mg and 38 mg iron arms (P<0.01 for both), decreasing the odds for low hemoglobin deferral about 50%.

Hemoglobin decreased >0.3 g/dL in the control groups (P<0.0001 for both the placebo and control letter groups), increasing the odds for low hemoglobin deferral about 70%.

“Interestingly, [being] in the iron status letter group did not affect hemoglobin that much in the longitudinal modeling of the donors,” Dr Mast noted.

In closing, he pointed out that the 19 mg and 38 mg iron pills were equally effective for mitigating iron deficiency and improving hemoglobin in these blood donors.

“From a physiology point of view, I think this is one of the most important results of this study,” Dr Mast said. “There’s absolutely no difference. There was no trend for 38 mg to be better than 19 in any analysis that we did.”

“There’s lots of reasons that could be happening, but I think it’s scientifically interesting and operationally interesting. And it’s important because we can tell donors—ask them to take a multivitamin with 19 mg of iron, and that will be sufficient to treat iron deficiency.”