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J. B. Sharma et al. / Journal of Pharmacy Research 2012,5(5),2881-2882
Research Article
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Efficacy of Ferrous bisglycinate (FeroseTM) in anemia during pregnancy
J. B. Sharma1 and K.H.Nagabhushan 2*
1
Deptt. of Obstetrics & Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110 029, India.
Received on:12-02-2012; Revised on: 17-03-2012; Accepted on:26-04-2012
ABSTRACT
Background:Anemia during pregnancy is very common in India affecting almost 80% women. Despite regular prescription of oral iron to almost all
pregnant women incidence remains high due to poor compliance due to side-effects of oral iron. The aim of present study to evaluate the effectiveness of
ferrous bisglycinate tablet in the control of iron deficiency in pregnant women.Materials and methods: The study was designed and performed as noncomparative, open labelled clinical trial. Total of 22 pregnant women were with anemia. The women were routinely followed up as per protocol; hemoglobin
(Hb) estimation was performed after 4 weeks of therapy.Results: After 4 week of treatment, there were significant increases in hemoglobin levels with mean
rise in hemoglobin level is 2.4 g/dL and it showed better compliance and lack of unwanted side-effects.Conclusion: To conclude, ferrous bisglycinate in dose
of 2 tablets a day is an effective treatment for anemia during pregnancy without any major side effects and with better compliance.
Keywords: Iron, anemia, hemoglobin, ferrous bisglycinate.
INTRODUCTION
Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and
prenatal and infant loss. Therefore, routine iron supplementation during the
second half of pregnancy has been recommended but iron-supplementation
programs, especially among pregnant women is poor, due in part to the side
effects associated with other iron salt preparations.
such as zinc and calcium, can be added to multivitamin preparations because
it does not affect the stability of vitamins and less likely to have any of the
gastrointestinal side-effects associated with commonly used iron salts. [2, 3]
Szarfarc SC et al., study on pregnant women concluded that daily supplementation with ferrous amino acid chelate was significantly more effective,
than supplementation with ferrous sulfate. [4]
Currently, there are many iron preparations available containing different This study was design to evaluate the effectiveness of ferrous bisglycinate
types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascor- tablet in the control of iron deficiency in pregnant women. The effectiveness
bate and ferrous bisglycinate (chelated form of iron).
of daily supplementation of iron from ferrous bisglycinate was evaluated by
measuring hemoglobin levels.
Product resulting from the reaction of a metal ion from a soluble salt with
amino acids to form coordinate covalent bonds, the resulting molecule is MATERIALS AND METHODS
called as chelate and chemical bonding process is called chelation. [1]
Study design:
Ferrous bisglycinate is highly stable and totally nutritionally functional che- This study was 4 weeks, non-comparative, open labeled, single centre study
late. It is an amino acid chelate which is formed by the binding of two to evaluate the effectiveness of ferrous bisglycinate (FeroseTM) tablet in pregmolecules of glycine to one Fe2+ atom. [1]
nant women with anemia. Pregnant women, age range of 18-30 years with a
Hb level between 8-10 g/dL were included in the study.Patients with associFollowing oral administration, ferrous bisglycinate adds to the intestinal in- ated conditions like megaloblastic anemia or pernicious anemia, thalassemia,
traluminal pool of inorganic, non-haem iron and is absorbed intact into the sickle cell or aplastic anemia, bleeding peptic ulcer, piles, esophageal varices,
mucosal cells of the intestine, and subsequently iron is dissociated from helminthiasis were excluded from the study. Also excluded were patients
ferrous bisglycinate and then distributed, reversibly bound to transferrin for suffering from severe or uncontrolled systemic and metabolic diseases and
utilisation in proteins, including storage proteins. [2]
who were on treatment with other haematinic agents within 24 hours before
the start of the study.
The main advantages of ferrous bisglycinate over other inorganic forms of
iron supplements are its high bioavailability in the presence of dietary inhibi- Treatment:
tors because it is theorized that the chelates prevents iron from binding to Ferrous bisglycinate tablet containing 30 mg elemental iron, 11 mg of elemeninhibitors in food (phytates) or precipitating as insoluble ferric hydroxide in tal zinc, 0.5 mg of folic acid and 7.5 µg of vitamin B12 , was given twice daily
the pH of the small intestine, does not inhibit absorption of other minerals for 4 weeks.
*Corresponding author.
Dr. K.H.Nagabhushan
Vice-President: Medico-Marketing Services,
Cosme Farma Laboratories Ltd.,
401, Sigma, Technology Street,
Hiranandani Gardens,
Powai, Mumbai- 400076,
Maharashtra, India
Clinical evaluation:
Evaluation was done on the basis of Hb estimation. Haemoglobin was measured prior to the administration and repeated after 4 weeks of therapy.
Safety and tolerability analysis:
Patients were monitored for any adverse effects. All adverse effects or unexpected events were recorded in the case report forms.
Journal of Pharmacy Research Vol.5 Issue 5.May 2012
2881-2882
RESULTS
Patient’s characteristics
A total of 25 pregnant women screened and enrolled in the study at single
centre. Two patients were lost to follow-up while 1 women suffering from
hypoplastic anemia and 22 patients completed the 4-weeks treatment period. Statistical analysis was performed on 22 completed patients. The mean
age of women was 25.2± 2.5 years and were in second or third trimester of
pregnancy.
Clinical evaluation
In the ferrous bisglycinate group, the Hb rise was 2.4 g/dL at the end of 4
weeks which was significantly higher (P < 0.05) compared to the baseline
value. (Table 1, Figure 1)
Table 1: Effects of ferrous bisglycinate treatment on haemoglobin levels.
Group
(N=22)
Haemoglobin g/dL (Mean±S.D) Mean rise in
Haemoglobin
Baseline
Week 4
in g/dL
Ferrous bisglycinate tablet
9.2±0.53
11.6±0.65*
Haemoglobin (g/dl)
J. B. Sharma et al. / Journal of Pharmacy Research 2012,5(5),2881-2882
Stastical analysis:
All values are expressed as Mean±S.D. Hemoglobin analysis was performed
by one-way analysis of variance (ANOVA) followed by Bonferonni’s post
test.
12
11
10
9
8
7
6
5
4
3
2
1
0
B a s e li n e
W e ek 4
D u r a t io n o f tre a tm e n t (i n w e e k s )
Figure 1: Comparison of Haemoglobin Level between Baseline and at
end of therapy.
According to study conducted in our hospital showed that rise in hemoglobin
is significantly (p<0.05) higher than baseline hemoglobin level, with greater
tolerability and lack of unwanted side effects. Hence it should be given as
single tablet a day for prophylaxis and one tablet twice a day for therapeutic
purpose.
In conclusion, findings of this study show that ferrous bisglycinate tablets
can be effectively used to prevent or treat the iron deficiency anemia in
pregnant women.
2.4
By one way ANOVA, *P<0.05 when compared to the corresponding baseline value.
Safety and tolerability analysis
All 22 patients tolerated the drug well. Only two women had mild nausea
which settled on changing the time of intake of iron tablets to after meals. As
this side effect was not serious enough to withdraw the therapy.
DISCUSSION
To prevent iron deficiency anemia during pregnancy supplemental iron is
advisable for all pregnant women. Women not receiving iron during pregnancy had exhausted iron stores at term and serum ferritin values stayed low
even at 6 months after delivery. [5]
According to Singh S et al, study on 375 adult female patients, 42-day daily
treatment with ferrous bisglycinate or ferrous sulphate resulted in significant
increase in hemoglobin (Hb) levels. On day 42, the mean increase in Hb of the
group receiving ferrous bisglycinate (22.72%) was significantly higher than
that of the group receiving ferrous sulphate (18.66%). [6]
REFERENCES
1. Ashmead SD. The chemisty of ferrous bisglycinate chelate. Archivos
latinoamericanos de nutricion 2001; 51(1): 7-12.
2. Ferrous bisglycinate as a source of iron for use in the manufacturing of foods and in food supplements: The EFSA Journal 2006;
299: 2-17.
3. Jeppsen RB, Borzelleca JF. Safety evaluation of Ferrous
bisglycinate. Food and chemical toxicology 1999; 37: 723-731.
4. Szarfarc SC, de Cassana LM, Fujimori E, Guerra-Shinohara EM,
de Oliveira IM. Relative effectiveness of iron bisglycinate chelate
(Ferrochel) and ferrous sulfate in the control of iron deficiency in
pregnant women. Arch Latinoam Nutr. 2001; 51(1): 42-7.
5. Puolakka J, Janne O, Pakarinen A, Vihko R. Serum ferritin as a
measure of stores during and after normal pregnancy with and
without iron supplements. Acta Obstet Gynecol Scand 1980; 95:
43–51.
6. Singh S, Singh S, Subhadra Lata, Jain R, Bissa U, T. Ramanidevi, et
al. Evaluation of efficacy and tolerability of ferrous bisglycinate
tablets in comparison with ferrous sulphate tablets in patients
with iron deficiency anemia. Journal of Pharmacy Research 2011;
4(8): 2836-2839.
Source of support: Nil, Conflict of interest: None Declared
Journal of Pharmacy Research Vol.5 Issue 5.May 2012
2881-2882