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Lactoferrin plus health education versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating iron deficiency anemia (IDA) in pregnancy: a randomized controlled trial.

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians
July 1, 2019
A M Darwish et al. (4 authors)
Journal ArticleRandomized Controlled TrialRetracted PublicationHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the efficacy and safety of oral lactoferrin plus health education versus total dose infusion of low-molecular weight iron dextran for treating iron deficiency anemia in pregnant women during their second and third trimesters.

Results Summary

Both treatments showed significant clinical improvement in anemia after 4 weeks, with no significant difference in hemoglobin level improvement. However, iron indices improved more with lactoferrin, while MCV and MCH improved more with iron dextran.

Population

Pregnant women in their second and third trimesters with iron deficiency anemia in Assiut, Egypt.

Effective Dosage

100 mg lactoferrin oral sachets twice daily; total dose infusion of low-molecular weight iron dextran (specific dosage not detailed).

Duration

4 weeks

Interactions

None mentioned

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
pineapple flavored lactoferrin oral sachets 100 mg twice daily with health education
decrease
anemia
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
showed a significant clinical improvement
#1
total dose infusion (TDI) of low-molecular weight (LMW) iron dextran
decrease
anemia
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
showed a significant clinical improvement
#2
pineapple flavored lactoferrin oral sachets 100 mg twice daily with health education
no change
mean Hb level
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
no statistically significant difference in mean Hb level improvement
#3
total dose infusion (TDI) of low-molecular weight (LMW) iron dextran
no change
mean Hb level
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
no statistically significant difference in mean Hb level improvement
#4
total dose infusion (TDI) of low-molecular weight (LMW) iron dextran
increase
mean corpuscular volume (MCV)
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
improved significantly more
#5
total dose infusion (TDI) of low-molecular weight (LMW) iron dextran
increase
mean corpuscular hemoglobin (MCH)
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
improved significantly more
#6
pineapple flavored lactoferrin oral sachets 100 mg twice daily with health education
increase
serum iron
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
were significantly more
#7
pineapple flavored lactoferrin oral sachets 100 mg twice daily with health education
increase
serum ferritin
cases with iron deficiency anemia in the second and third trimester of pregnancy
-
were significantly more
#8
proper health education of the pregnant women with nurse recommendations of balanced diet containing good sources of iron
increase
awareness of pregnant women
pregnant women
-
would increase awareness
#9
proper health education of the pregnant women with nurse recommendations of balanced diet containing good sources of iron
decrease
iron deficiency anemia (IDA) with its serious sequel
pregnant women
-
would help eradicate
#10
Abstract

BACKGROUND: Iron deficiency anemia (IDA) is one of the most common medical disorder disturbing pregnancies particularly in low resources countries, and contributes significantly to morbidities and mortalities. Thus, early diagnosis and prompt management of IDA is highly recommended. AIM: To Test the efficacy and safety of oral lactoferrin plus health education provided by a nurse versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating IDA in the second and third trimester of pregnancy. DESIGN: A prospective interventional, randomized, parallel-group, single-center longitudinal study. SETTING: Woman's Health Assiut University Hospital, Assiut, Egypt, at the outpatient clinic and inpatient unit. It comprised 120 cases divided into two groups as pineapple flavored lactoferrin oral sachets 100 mg twice daily with health education (group A) and TDI of LMW iron dextran (group B). MAIN OUTCOME MEASURES: The primary efficacy parameter was clinical improvement and the amount of increase in hemoglobin concentration by 4 weeks after therapy, secondary outcome measures included measurement of the rest of RBC, and iron indices, the adverse effects related to iron therapy and the patient compliance to the treatment. RESULTS: There was insignificant difference between both groups regarding sociodemographic data, parity and mean gestational age. Both groups showed a significant clinical improvement of anemia 4 weeks post-therapy. There was no statistically significant difference in mean Hb level improvement in both groups after 1 month of therapy. However, mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) improved significantly more in group B than A while iron indices (serum iron and serum ferritin) were significantly more in group A than group B. CONCLUSIONS: Pineapple flavored lactoferrin oral sachets plus health education can be widely used as an alternative to TDI iron dextran supplementation due to clinical as well as laboratory improvement of IDA during pregnancy after 1 month of treatment. Proper health education of the pregnant women with nurse recommendations of balanced diet containing good sources of iron would increase awareness of pregnant women and help eradicate IDA with its serious sequel during pregnancy.

Medical Subject Headings (MeSH)
Administration, IntravenousAdministration, OralAdultAnemia, Iron-DeficiencyAnti-Infective AgentsFemaleHealth EducationHematinicsHumansIron-Dextran ComplexLactoferrinPregnancyPregnancy Complications, HematologicProspective StudiesYoung Adult
Study Links
Quality Scores
Safety80
Efficacy85/10
Quality75/10
Citation Metrics
Total Citations5
Citations/Year0.8
Relative Citation Ratio0.46
NIH Percentile24.8%
Research Impact Scores
APT Score0.25
Weight Score1.98
Normalized Score0.81
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