Effects of Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin in pregnant women affected by Iron Deficiency Anemia: preliminary results from a prospective, double-blind, randomized controlled trial
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This study compared the effects of micronized dispersible ferric pyrophosphate combined with alpha-lactalbumin versus ferrous gluconate in treating iron deficiency anemia in pregnant women. Fifty pregnant women with anemia were randomly assigned to receive either 30 mg of ferric pyrophosphate plus 300 mg of alpha-lactalbumin or 80 mg of ferrous gluconate daily for 30 days. The combination treatment was more effective at increasing hemoglobin, ferritin, and serum iron levels with no reported side effects, while the ferrous gluconate group saw increases but also had a 24% side effect rate. The combination treatment was more effective at treating iron deficiency anemia in
Effects of Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin in pregnant women affected by Iron Deficiency Anemia: preliminary results from a prospective, double-blind, randomized controlled trial
- 1. Effects of Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin in pregnant women affected by Iron Deficiency Anemia: results from a prospective, double-blind, randomized controlled trial Antonio Simone Laganà Department of Obstetrics and Gynecology “Filippo Del Ponte” Hospital University of Insubria Varese, Italy
- 2. Background Iron deficiency is the most common cause of anemia in the world and represents a major challenge in healthcare policy. In particular, Iron Deficiency Anemia is the leading cause of anemia-related disability, especially in reproductive aged women. (Kassebaum et al., Blood. 2014) Both anaemic and non-anaemic iron deficiencies in pregnancy may have severe consequences on maternal-fetal outcomes: increased preterm labour, preeclampsia, maternal sepsis, fetal loss or even perinatal death, neonatal cognitive impairments. (Scholl, Nutr Rev. 2011) (Congdon et al., J Pediatr. 2012) Anemia is particularly frequent during pregnancy: recent data reported an estimated prevalence of 38%, equivalent to 32 million women worldwide. (Stevens et al., Lancet Glob Health. 2013)
- 3. Background Although intravenous iron administration seems to be very effective for the treatment of Iron Deficiency Anemia during pregnancy, to date oral iron supplementation is preferred whenever it is possible for its feasibility and better compliance. The major problem with oral iron therapy in its classic ferrous form is poor tolerability and gastrointestinal side effects such as abdominal pain, diarrhea and constipation (up to 40% of patients) (Wu & Tsai, Drug Res (Stuttg). 2016)
- 4. Background The oral preparations of micronized dispersible ferric pyrophosphate and Alpha-Lactalbumin opened a new horizon. This type of micro-coated iron shows similar bioavailability compared to ferrous sulfate. (Fidler et al., Br J Nutr. 2004) Alpha-Lactalbumin was found to play a positive role on gut microbiota, likely increasing the iron absorption. (Brück et al., J Pediatr Gastroenterol Nutr. 2006)
- 5. Aim To evaluate the effects of micronized dispersible ferric pyrophosphate combined with Alpha- Lactalbumin respect to Ferrous Gluconate in pregnant women affected by Iron Deficiency Anemia.
- 6. Patients and Methods Prospective, double-blind, randomized controlled trial enrolling 50 second-trimester singleton pregnancies in women affected by Iron Deficiency Anemia (Hb levels less than 10.5 g/dL, ferritin less than 10-15 mcg/L). Exclusion criteria: •any other kind of pre-pregnancy or pregnancy-related diseases •twin pregnancies •any other kind of pharmacologic/nutraceutical treatment (beside folic acid supplementation) before or during pregnancy
- 7. Patients and Methods We randomized the patients in a non-stratified 1:1 ratio in two groups: 1.The first one orally administered with 30 mg of micronized dispersible ferric pyrophosphate combined with 300 mg of Alpha- Lactalbumin 2.The second one (controls) orally administered with 80 mg of Ferrous Gluconate. Both groups took one daily tablet for 30 days.
- 8. Patients and Methods Primary outcomes: •Hb (g/dL) •ferritin (mcg/L) Secondary outcomes: •red blood cells •serum iron (mcg/dL) •hematocrit (Hct, %) •side effects Timing of evaluation: •baseline evaluation (T0) •15 days (T1) •30 days (T2)
- 9. Results We did not find significant differences between the two groups for mean age, gestational age at enrollment and parity. The cumulative side effects rate was 24% in Ferrous Gluconate group, whereas Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin group did not show any significant side effect (p= 0.02). All the enrolled patients completed the trial (no drop out).
- 10. Results after 15 days (T1) In the group treated with Micronised Dispersible Ferric Pyrophosphate combined with Alpha- Lactalbumin there was a significant increase of Hb, ferritin, serum iron and Hct. In the group treated with Ferrous Gluconate there was a significant increase of Hb, ferritin, serum iron and Hct. Nevertheless, the increase of Hb, ferritin and serum iron was higher in Micronised Dispersible Ferric Pyrophosphate combined with Alpha- Lactalbumin group respect to Ferrous Gluconate group.
- 11. Results after 30 days (T2) In the group treated with Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin all the investigated parameters were significantly increased respect to baseline. In the group treated with Ferrous Gluconate all the investigated parameters were significantly increased respect to baseline. Nevertheless, the increase of Hb, ferritin, RBCs, serum iron and Hct was higher in Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin group respect to Ferrous Gluconate group.
- 12. Results after 30 days (T2) The comparison between the two groups after 30 days (T2) showed a significant more marked increase of Hb (p<0.0001) and serum iron (p=0.03) in Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin group respect to Ferrous Gluconate group.
- 13. Conclusion Micronised Dispersible Ferric Pyrophosphate combined with Alpha-Lactalbumin exerts a higher efficacy in improving some pivotal parameters and shows a safer profile than Ferrous Gluconate for the treatment of Iron Deficiency Anemia in pregnant women.
- 14. Thanks for your attention! Lake of Varese