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Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy

Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03484845
Enrollment
150
Registered
2018-04-02
Start date
2018-11-01
Completion date
2019-12-01
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia of Pregnancy

Brief summary

This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.

Detailed description

Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic . Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type of anemia Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis. The daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss

Interventions

DRUGLactoferrin and ferrous fumarate

* Group 1:include 50 women will receive oral lactoferrin 100mg twice daily . * Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily . * Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily .

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women from 24-36 weeks of gestation. * Mild to moderate anemia.

Exclusion criteria

* Women with a history of anemia due to any other causes other than IDA. * Severe anemia requiring blood transfusion. * History of peptic ulcer. * known hypersensitivity to iron preparations.

Design outcomes

Primary

MeasureTime frameDescription
Increase in blood hemoglobin.one monthmean difference in hemoglobin level between pre treatment and post treatment.

Contacts

Primary Contactamaal khalil, master
amaal.moussa@gmail.com02201154883113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026