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

Assiut University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Iron Deficiency Anemia of Pregnancy

Treatments: Drug: Lactoferrin and ferrous fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT03484845

u1111-1210-1436

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Oral lactoferrin

Active Comparator group

Description:

women who take oral lactoferrin sachets 100 mg twice daily for one month.

Treatment:

Drug: Lactoferrin and ferrous fumarate

Oral ferrous fumarate

Active Comparator group

Description:

women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.

Treatment:

Drug: Lactoferrin and ferrous fumarate

Combined lactoferrin & ferrous fumarate

Active Comparator group

Description:

women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.

Treatment:

Drug: Lactoferrin and ferrous fumarate