Lecture during the "18th World Congress of Gynecological Endocrinology" (Florence, 7-10 March 2018).

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