Bharat school of Pharmacy, JNTUH, Ranga Reddy, Telangana, India-501510.
Background: Iron deficiency anaemia in pregnancy is a nutritional disorder characterized by insufficient iron levels, leading to reduced haemoglobin production. This condition poses significant risks to both maternal and fatal health including increased chances of preterm birth, low birth, weight and maternal morbidity. It often results from inadequate dietary intake, poor iron absorption, or increased iron requirements during pregnancy. Early diagnosis and appropriate management through iron supplementation and dietary adjustments are crucial to mitigate adverse outcomes and promote healthy pregnancy outcomes. Objective: To evaluate the efficacy and compliance with oral ferric pyrophosphate and oral ferrous ascorbate Method: A prospective observational study for a duration of 3 months with 83 subjects divided into 2 groups Group-Awith 43 subjects receiving Ferric ascorbate and Group-B with 40 subjects receiving with ferric pyrophosphate. Both the groups received a dose of 100mg oral tablets. Result: Ferrous Ascorbate showed an increase of Hb levels from 9.52 g/dL to 12.23 g/dL Serum Ferritin increased from 74.56ng/mL to 288.23ng/mL whereas in Ferric Pyrophosphate the Hb levels resulted from 9.82g/dL to 11.16g/dL and Serum Ferritinvalues increased from 82.63ng/mL to 314. 18ng/mL. Conclusion: Efficacy of Ferrous Ascorbate group was found to be better, but the Ferric Pyrophosphate group had better compliance compared to FerrousAscorbate.
Anaemia is defined by the World Health Organization (WHO) as haemoglobin (Hb) levels of less than 11 g/dL for pregnant women and 12 g/dL for nonpregnant adults (1,2). From 2015 to 2016, more than half of Indian women aged 15 to 49 were anaemic.
The Ministry of Health and Family Welfare of India conducted National Family Health Surveys (NFHS) in 2005-2006 and 2015-2016, which revealed a high prevalence of anaemia among women(3,4). Iron Deficiency Anaemia (IDA) during pregnancy is the condition that can have detrimental effects on the health and well-being of both the expectant mother and her developing fetus. Preterm delivery, low birth weight, intrauterine development retardation, postpartum haemorrhage, heart failure, and an elevated risk of infections are among the consequences(5). For the treatment of mild to moderate IDA, oral iron supplementation is employed, but parenteral therapy is required for severe cases. For patients who are malabsorption or have an intolerance to oral iron preparations, parenteral preparations are also the recommended option. Iron supplementation by oral formulations is both efficient and well-tolerated. To reach the desired Hb levels, iron supplementation should be continued for at least two months, depending on the specific patient. For optimal therapy compliance, an iron preparation with a favorable tolerability is therefore necessary. Iron deficiency anemia is most usually treated with ferrous forms of ascorbate, sulphate, fumarate, gluconate, glutamate, succinate, and lactate, as well as ferric forms such as ferric pyrophosphate and ferric orthophosphate iron supplements. The physiological form of iron that the intestines absorb is when it is in the ferrous state. In the alkaline pH of the small intestine, iron in the ferric form is transformed into insoluble ferric hydroxide, which has reduced absorption (iron from supplements containing ferric forms must be converted into ferrous forms for absorption following oral therapy)(6). The advantage of ferrous ascorbate over other ferrous salts in iron supplements is that it is known to stay soluble in the small intestine's alkaline pH(7). However, the gastrointestinal mucosa is toxic to oral iron supplements, which are typically in the form of ferrous (Fe2+) salts, and intolerance is widespread, leading to poor patient compliance and treatment failure(8). Given that ferrous ascorbic causes metallic taste in the mouth and results in black or tarry stools, doctors typically prescribe ferric pyrophosphate instead of ferrous ascorbate(9). Hence, the goal of the current study was to evaluate the effectiveness, tolerability, compliance, and adverse effects of the prescribed Ferric pyrophosphate over Ferrous ascorbic for the treatment of IDA in expectant mothers.
MATERIALS AND METHODS
Study setting and design:
This is a prospective observational study which was conducted for about 3months duration after the approval of the Institutional Ethics Committee at Durgabai Deshmukh Hospital and Research Centre – Hyderabad, India. After providing the complete details about this study to the patients, they were given Informed consent and Patient consent forms and upon their willingness to participate in the study, we have recruited the subjects.
Study criteria:
Inclusion Criteria:
According to the WHO guidelines for IDA, Pregnant women of gestational age between 12 to 26 weeks with moderate anaemia. Having blood haemoglobin levels between 7 and 9.9 g/dl shown in (Fig. 1)
Exclusion Criteria:
Sampling strategy and size:
We recruited 98 subjects based on their interest to participate. Patients were randomly allocated into two groups –Group-A: Ferrous Ascorbate group and Group-B: Ferric Pyrophosphate group, each group consisting of equal number of participants ie) 49 in each group.
Ferric pyrophosphate:
Trade name:Ferrinto
Chemical formula[10]: Fe4 (P2 O7)3
Manufacturer, city and the country: Swiss gamier biotech Pvt.Ltd, Himachal Pradesh, India.
Ferric ascorbate:
Trade name: Orofer XT.
Chemical formula[11]: C12H14FeO12.
Manufacturer, city and the country: Emcure pharmaceuticals LTD, Bari- brahmana, Jammu, India.
Study procedure:
Prior to the starting of the study patient counselling was given to all the participants about the medication and the importance of diet guidelines and told them to call the Principal Investigator anytime regarding any queries related to medicines. Group-A received 100mg of Ferrous Ascorbate tablet per day and Group-B received 100mg of Ferric Pyrophosphate tablet per day. They were followed up every 30 days for 2 visits, to observe the improvement in the Haemoglobin (Hb) levels, Total iron binding capacity (Tibc), and serum ferritin, also any adverse drug reactions. We took an initiative to contact the participants every week so as to address any medication compliance issues. The data was secured and stored safely in Microsoft excel.
Statistical tools used:
Qualitative data was presented as number and percentage and Quantitative data was presented as mean and standard deviation. Statistical significance between percentages was analysed using the t-test and Chi-square test. The complete analysis was done by using SPSS statistical package 26th version.
RESULTS
After 2nd review checkup, out of 98 patients recruited 15 were lost to follow-up between 1st and 2nd review visits. Group-A lost 6participants while Group-B lost 9participants. And finally, we assessed the results of 43 participants in Group-A and 40 in Group-B. The results presented below are the values that are checked before the start of the study Day - 0 and after the IDA therapy for about 2months duration on Day-60. Laboratory test results for Hb, RBC’s and Serum Ferritin for the Comparison of Group-A and Group-B are described below in (Table:1)
Hemoglobin:
Hb levels in Ferric Ascorbate group prior to the initiation of therapy on DAY-0 had 9.52 g/dL with Mean standard deviation of (0.96) while after 2nd review of therapy DAY-60 was found to be 12.23 g/dL with Mean standard deviation of (1.39) which showed a significant change by 2.71g/dL whereas in Ferrous Pyrophosphate had 9.82g/dL during the initiation of therapy and later increased to 11.16g/dL.
Red blood cells count:
RBC’S count in Ferric Ascorbate group had 3.35millions/cumm and later increased to 4.27millions/cumm while in Ferrous Pyrophosphate group the value increased from 3.47millions/cumm to 3.94millions/cumm.
Serum Ferritin:
Ferrous Ascorbate group increasedSerum Ferritin levels from 74.56 to 288.23ng/mL and inFerric Pyrophosphate the values increased from 82.63ng/mL to 314. 18ng/mL.
Table1: Comparison Of Blood Tests for Group-A And Group-B
|
Variable |
Ferrous Ascorbate
|
P value |
Ferric Pyrophosphate
|
P value |
||
|
DAY-0 Mean (SD) |
DAY-60 Mean (SD) |
Day-0 Mean (SD) |
DAY-60 Mean (SD) |
|||
|
Hb |
9.52 (0.96) |
12.23 (1.39) |
<0.001 |
9.82 (1.20) |
11.16 (1.59) |
<0.001 |
|
RBC count |
3.35 (0.39) |
4.27 (0.37) |
<0.001 |
3.47 (0.42) |
3.94 (0.37) |
<0.001 |
|
Platelet count |
2.76 (1.71) |
3.48 (0.63) |
0.003 |
2.12 (0.61) |
2.54 (0.68) |
<0.001 |
|
TIBC |
488.44 (55.94) |
421.26 (33.05) |
<0.001 |
467.05 (40.69) |
380.15 (62.16) |
<0.001 |
|
Serum ferritin |
74.56 (86.98) |
288.23 (98.74) |
<0.001 |
82.63 (79.92) |
314.18 (52.42) |
<0.001 |
The side effects such as nausea, vomiting, abdominal pain was reported in (Table: 2) for both the groups. Group-A had reported 6.97% and Group-B reported 2.5%.
Table2: Comparison of Side effects in Ferrous Ascorbate and Ferric Pyrophosphate
|
Side effects |
Medication |
|
|
Ferrous Ascorbate Number (%) |
Ferric Pyrophosphate Number (%) |
|
|
Yes |
3 (6.97) |
1 (2.5) |
|
No |
40 (93.03) |
39 (97.5) |
|
Total |
43 (100) |
40 (100) |
The medication compliance or adherence was 88.38% in Ferrous Ascorbate group and Ferric Pyrophosphate group had 97.5% presented in (Table:3).
Table3: Medication compliance in Group-A and Group-B
|
Compliance |
Medication |
|
|
Ferrous Ascorbate Number (%) |
Ferric Pyrophosphate Number (%) |
|
|
Yes |
38 (88.38) |
39 (97.5) |
|
No |
5 (11.62) |
1 (2.5) |
|
Total |
43 (100) |
40 (100) |
Medicine was discontinued in both the groups; 4 subjects in Group-A which is (9.30%) and 1 subject in Group-B which is (2.5%)
Table4: Comparison Of Medicine Discontinued in Both the Groups
|
Discontinue medication |
Medication |
|
|
Ferrous Ascorbate Number (%) |
Ferric Pyrophosphate Number (%) |
|
|
Yes |
4 (9.30) |
1 (2.5) |
|
No |
39 (90.70) |
39 (97.5) |
|
Total |
43 (100) |
40 (100) |
DISCUSSION
Even though low-income nations are where IDA is most common. Prevalence of anemia during pregnancy is greater than 20% in more than 80% of the world's nations(12). Most of this discrepancy can be attributed to the regular blood loss that occurs during menstruation, which is frequently linked to a low iron diet(13,14). This study when compared Ferrous Ascorbate therapy with Ferric Pyrophosphate therapy found that there is a significant difference between both the groups. Ferrous Ascorbate showed better results in Hb levels by increase of 2.71g/dL while it increased 1.34g/dL in Ferric Pyrophosphate group. RBC count increased by 0.92millions/cumm in Group-A and 0.47millions/cumm in Group-B. Platelet count had a difference of 0.72Lakhs/Cumm in Ferrous Ascorbate while 0.42Lakhs/Cumm in Ferric Pyrophosphate group. Serum Ferritin levels had an increase of 213.67ng/mL in Group-A whereas 231.55ng/mL in Group-B. Tibc was found to be decreased in both the groups with more reduction in Ferric Pyrophosphate group. Coming to the side-effects compared in both the groups, 3 subjects from Ferrous Ascorbate group and only 1 person from Ferric Pyrophosphate complained about side-effects. Medication Compliance issues were reported in 5patients and out of which 4patients discontinued medicines in Ferrous Ascorbate group while 1person reported and discontinued medicine from Ferric Pyrophosphate group.
Characteristics of both the Medicines:
Ferrous Ascorbate -
Ferric Pyrophosphate -
CONCLUSION
This shows that though Ferrous Ascorbate therapy had better efficacy when compared with Ferric Pyrophosphate therapy, people felt better with Ferric Pyrophosphate. Ultimately, the choice between ferrous ascorbate and Ferric Pyrophosphate should be guided by individual patient needs, tolerability, and the specific clinical scenario.
REFERENCES
Divya Sri, Keerthika B., Priyanka B., P. Harith, Mahesh Gomasa, Dr. Swathi Boddupally*, Study On Efficacy and Compliance of Oral Supplements with Ferric Pyrophosphate and Ferrous Ascorbate in Iron Deficiency Anaemia During Pregnancy. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 1080-1086 https://doi.org/10.5281/zenodo.15354355
10.5281/zenodo.15354355
