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

Iron Deficiency Anemia of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03484845
• Other study ID #: u1111-1210-1436
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: amaal khalil, master
• Phone: 02201154883113
• Email: amaal.moussa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia of Pregnancy

Intervention

Drug:
• Lactoferrin 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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in blood hemoglobin.	mean difference in hemoglobin level between pre treatment and post treatment.	one month