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.

Table 1: Demographic data

Table 2:Hb level(gm/dL) before and after treatment.

Table 3: demonstrates the adverse effects with iron use.

1.         World Health Organization (1972) Report of a WHO group of experts on nutritional anaemias. Geneva, Switzerland 1972.

2.         World Health Organization (1992) The prevalence of anaemia in women: a tabulation of available information, 2nd ed. Geneva, Switzerland 1992.

3.         Singh K, Fong YF, Kuperan P (1998) A comparison between intravenous iron polymaltose complex (FerrumHausmann) and oral ferrous fumarate in the treatment of iron deficiency anemia in pregnancy. Eur J Haematol 60: 119-124.

4.         Metz-Boutique MH, Jolles J, Mazurier J, Schoentgen F, Legrand D, et al. (1984) Human lacto transferrin: amino acid sequence and structural comparisons with other transferrins. Eur J Biochem 145: 659-676.

5.         Recommendations for clinical Practice-Optimal methods for educating pregnant women, French National Health Authorities (Haute Autorit’e de Sant’e), 2005.

6.         Tsuji S, Uehori J, Matsumoto M, Suzuki Y, Matsuhisa A, et al. (2001) Human intelectin is a novel soluble lectin that recognizes galactofuranose in carbohydrate chains of bacterial cell wall. J BiolChem 276: 23456-23463.

7.         Brock JH (2002) The physiology of lactoferrin. Biochem Cell Biol 80: 1-6.

8.         Hernell O, Lonnerdal B (2002) Iron status of infants fed low-iron formula: no effect of added bovine lactoferrin or nucleotides. Am J ClinNutr 76: 858-864.

9.         Paesano R, Torcia F, Berlutti F, Pacifici E, Ebano V, et al. (2006) Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant women. Biochem Cell Biol 84: 377-380.

10.     Rezk M, Dawood R, Abo-Elnasr M, Al Halaby A, Marawan H (2016) Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial. J Matern Fetal & Neonatal Med 29: 1387-1390.