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

NCT ID: NCT03484845

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-01

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

Conditions

Iron Deficiency Anemia of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral lactoferrin

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

Group Type: ACTIVE_COMPARATOR

Lactoferrin and ferrous fumarate

Intervention Type: DRUG

• 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 .

Oral ferrous fumarate

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

Group Type: ACTIVE_COMPARATOR

Lactoferrin and ferrous fumarate

Intervention Type: DRUG

• 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 .

Combined lactoferrin & ferrous fumarate

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

Group Type: ACTIVE_COMPARATOR

Lactoferrin and ferrous fumarate

Intervention Type: DRUG

• 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 .

Interventions

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 .

Intervention Type: DRUG

Other Intervention Names

pravotin sachets and vitayami tablets

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amaal Khalil Hamed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

amaal khalil, master

Role: CONTACT

amaal.moussa@gmail.com

02201154883113

Other Identifiers

u1111-1210-1436

Identifier Type: -

Identifier Source: org_study_id