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

Phase 1

• Conditions: Iron Deficiency Anemia of Pregnancy
• Interventions: Drug: Lactoferrin and ferrous fumarate

• Registration Number: NCT03484845
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-30
• Last Update Posted: 2018-07-03
• Study Start: 2018-11-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral ferrous fumarate	Lactoferrin and ferrous fumarate	women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.
Combined lactoferrin & ferrous fumarate	Lactoferrin and ferrous fumarate	women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.
Oral lactoferrin	Lactoferrin and ferrous fumarate	women who take oral lactoferrin sachets 100 mg twice daily for one month.

Primary Outcome Measures

Name	Time	Method
Increase in blood hemoglobin.	one month	mean difference in hemoglobin level between pre treatment and post treatment.