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

Sponsors

Lead Sponsor: Assiut University

Source 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

Overall Status Unknown status
Start Date November 1, 2018
Completion Date December 1, 2019
Primary Completion Date December 1, 2019
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Increase in blood hemoglobin. one month
Enrollment 150
Condition
Intervention

Intervention Type: Drug

Intervention Name: Lactoferrin and ferrous fumarate

Description: 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 .

Other Name: 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.

Gender: Female

Minimum Age: 16 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: amaal khalil, master

Phone: 02201154883113

Email: [email protected]

Verification Date

June 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: Amaal Khalil Hamed

Investigator Title: principal investigator

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Oral lactoferrin

Type: Active Comparator

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

Label: Oral ferrous fumarate

Type: Active Comparator

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

Label: Combined lactoferrin & ferrous fumarate

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov