Ferrous Sulphate In Comparison to Lactoferrin in Managing Anemia in Gestation
Ahmed Hassan Sayed Ahmed*
Department of Obstetrics and Gynecology, Faculty of Medicine, Helwan University, Cairo, Egypt
*Corresponding author: Ahmed Hassan Sayed Ahmed, Department of Obstetrics and Gynecology, Faculty of Medicine, Helwan University, Cairo, Egypt. Email: dra7mad7asan@icloud.com
Received Date: 26 December, 2018; Accepted
Date: 11 January, 2019; Published Date: 18 January, 2019
Citation:Ahmed AHS(2019) Ferrous
Sulphate in Comparison to Lactoferrin In Managing Anemia in Gestation. GynecolObstet Open Acc: OBOA-133. Doi: 10.29011/
2577-2236/100033
1. Abstract
1.1. Aim: The aim was to comparethe effectiveness offerrous sulphate to lactoferrin in managing anemia with gestation.
1.2. Materials and methods: This is a prospectiverandomized, parallel-group, single-center study was conducted in the Obstetrics and Gynecology AljazeerahHospital from April 2017 till May 2018, Egypt and included a total of 400 pregnant lady in the second trimester who were enrolled and randomly distributedeither to receive 150 mg of dried ferrous sulphate capsules or lactoferrin 250 mg capsules once daily for 12weeks. The primary efficacy parameter was the amount of increase in hemoglobin concentration by 4 and 8 weeks, the adverse effects related to iron therapy and the patient compliance to the treatment.
1.3. Results: In the present study, there was a netincrease in hemoglobinafter 8 weeksas a result of receivinglactoferrinincomparison to ferrous sulfate with a statistically significant P value(p˂ 0.001).
1.4.
Conclusion: Supplementation
with Lactoferrinhasbetterresultthan ferrous sulfatein pregnant females that had
anemia with gestation in elevating hemoglobin leveland haslesserGIT upsetand
better compliance.
1. Introduction
Iron Deficiency Anemia (IDA)happens when theironfails to meet upnormal redblood cell manufacture and is considered the most frequentcauseof anemia[1]. The incidenceof anemiain the developingcountriesranges from thirty-five to seventy five percent. [2]Oral iron ispresentthe most commonlyavailable are ferrous sulphate and ferric forms. Most of these preparations differin their, effectiveness,adverse outcome andbioavailability[3].
Lactoferrinis a glycoprotein, and a member of a transferrin family that is related totheproteinsthathas the abilityto bindand transferiron. [4]HB levelcould be estimated usingspectrophotometry [5].
2. Patientsand methods
The study protocoland complications were
fully explainedto all participants and a writteninformed consent was taken
before participation in the study.Eightypatients were required in each group
for the study to have 90% power to detect 10% difference betweentwo groups
regarding success rate (p = 0.05, two-sided). To compensate for possible
non-evaluable data, we enrolled 200 participants in each group. A total of 414
pregnant women were enrolled and randomly assigned into two study groups using
a computerized random number generator in a sequence of sealed, numbered opaque
envelopes, with a 1:1 randomization ratio. 14 patients were dropped out (6
discontinued drug intake and 8 lost follow-up).
A total of 400 pregnant women completed the study. The patients were assigned to take the medication orally, once daily after lunch. Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 h before or after iron capsules. Group 1 (Lactoferrin group): included 200 pregnant women who received lactoferrin 250 mg capsules (Jarrow Formulas, Egypt) once daily for eight consecutive weeks. Group 2 (Ferrous group): included 200 pregnant women who received 150 mg of dried ferrous sulphate capsules (Ferrofol capsules, EIPICO, Egypt) once daily for twelve consecutive weeks. Pregnant women with single fetus, in the second trimester, with IDA (hemoglobin level less than 11 g/dL and ferritin levels less than25ng/dL) were enrolled.
Women with a history of anemia due to any other causes, such as chronic blood loss, hemolytic anemia and thalassemia (including thalassemic trait), severe anemia requiring blood transfusion, bronchial asthma, clinical and/or laboratory evidence of hepatic, renal, hematologic or cardiovascular abnormalities, history of peptic ulcer, hypersensitivity to iron preparations and treatment with any other iron preparation in the last one month before study entry and suspected acute infection were excluded from the study.
The primaryoutcome was the amount of increase in hemoglobin concentration by 4and 8 weeks, the adverse effects (the patients were asked to report anyunacceptedsymptoms during the study period) related to iron treatmentand the patient compliance to treatment. Obstetric outcome in terms of gestational age at delivery, mode of delivery, maternal complications (postpartum hemorrhage and defective lactation) and neonatal outcome (neonatal weight, admission to neonatal intensive care unit and neonatal death defined as death in the first four weeks after birth) were assessed as a secondary outcome.
2.1. Statistical methods
Statistical analysis Data were collected, tabulated, statistically analyzed by computer using SPSS version 16 (SPSS Inc., Chicago, IL), two types of statistics were done: Descriptive statistics Quantitative data are expressed to measure the central tendency of data and diversion around the mean, Mean (x) and Standard Deviation (SD). Analytic statistics Chi-Square (x2) and t-test were used to compare two groups. All these tests were used as tests of significance at p value40.05 was considered statistically nonsignificant. p value 0.05 was considered statistically significant. p value 0.001 was considered statistically highly significant.
3. Results(Tables 1-3)
4. Discussion
Previous researchesrevealedinconclusive data showingimprovement or decreasingiron absorption.[6-8]In the present study, there was a netincrease in hemoglobinafter 8 weeksas a result of receivinglactoferrinincomparison to ferrous sulfate with a statistically significant P value(p˂ 0.001). Recently, a randomized trial that includedthree hundredladiesat different trimesters of gestationorally administratedferrous sulfateor thirty percentiron-saturated bovine lactoferrin, revealed an increased hemoglobin and total serum iron concentrationsin ladieswho receivedbovine lactoferrinthanin women whoreceivedferrous sulfatewith the absence of adverse effects[9].Also, in the current study, the GIT complications occurred more frequently with the ferrous sulphate receiving pregnant ladies with a statistically significant P value(p ˂ 0.001).
While in the current study, the number of ladieswho asked to replacethe medicationwas greater in the ferrous sulphateusingpatientswith a statistically significant P value(p ˂ 0.001).In a previousstudy made by Mohamed Rezket,al 2015 ,theyconcludedthatlactoferrinincreased hemoglobin levelmore than ferrous sulphatein pregnant females who had anemia with gestationwithlesser side effects[10].
In the current study,in correspondenceto the data revealedsupplementation with Lactoferrin hasbetterresultthan ferrous sulfatein pregnant females that had anemia with gestation in elevating hemoglobin leveland haslesserGIT upsetand better compliance.But,futureresearches mustbe madeto reachmore conclusive data.
5. Conclusion
supplementation with Lactoferrin hasbetterresultthan ferrous sulfatein pregnant females that had anemia with gestation in elevating hemoglobin leveland haslesserGIT upsetand better compliance.
(Lactoferringroup) | (Ferrous group) | p value | |
Age | 23.5±6.19 | 23.6±6.66 | ˃0.05* |
Parity | 1.62±2.38 | 1.70±2.30 | ˃0.05 |
GA at inclusion | 18.42±2.79 | 18.11±2.84 | ˃0.05 |
BMI at inclusion | 22.88±3.97 | 22.92±3.93 | ˃0.05 |
No of ANC visits | 2.06± 4.22 | 2.18±4.16 | ˃0.05 |
Table 1: Demographic data
(Lactoferringroup) | (Ferrousgroup) t | t-test | p value | |
Level of Hemoglobinat start | 8.1 ±0.61 | 8±0.699 | 1.553 | ˃0.05 |
Hemoglobin level After 4 weeks | 9.46±0.42 | 8.7 ±0.722 | 13.306 | ˂0.001* |
Hemoglobin level After 8 weeks | 10.52±0.29 | 9.23 ±0.633 | 25.430 | ˂0.001 |
Net increase in hemoglobin | 2.42 ±0.52 | 1.23 ±0.23 | 29.281 | ˂0.001 |
Table 2:Hb level(gm/dL) before and after treatment.
(Lactoferringroup) | (Ferrousgroup) | Chi square | p value | |
GIT complications | 20 | 120 | 109.980 | ˂0.001* |
Abdominal pain | 40 | 120 | 66.667 | ˂0.001 |
Vomiting | 20 | 60 | 25 | ˂0.001 |
Constipation | 40 | 120 | 66.667 | ˂0.001 |
Dark stools | 0 | 60 | 70.588 | ˂0.001 |
Want to stop intake | 0 | 40 | 44.444 | ˂0 .001 |
Table 3: demonstrates the adverse effects with iron use.