Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

NCT ID: NCT03759353

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2018-11-20

Brief Summary

The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.

Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.

This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.

Conditions

Iron Deficiency Anemia

Study Design

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

Study Groups

Lactoferrin Group

Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.

Group Type: ACTIVE_COMPARATOR

Baseline ferritin level

Intervention Type: DIAGNOSTIC_TEST

At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

Lactoferrin

Intervention Type: DRUG

lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).

Follow up ferritin level

Intervention Type: DIAGNOSTIC_TEST

Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

Ferrous Sulfate Group

Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.

Group Type: ACTIVE_COMPARATOR

Baseline ferritin level

Intervention Type: DIAGNOSTIC_TEST

At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

Ferrous Sulfate

Intervention Type: DRUG

200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.

Follow up ferritin level

Intervention Type: DIAGNOSTIC_TEST

Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

Interventions

Baseline ferritin level

At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

Intervention Type: DIAGNOSTIC_TEST

Lactoferrin

lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).

Intervention Type: DRUG

Ferrous Sulfate

200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.

Intervention Type: DRUG

Follow up ferritin level

Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Pravotin; Feosol

Eligibility Criteria

Inclusion Criteria

• Pregnant women with single fetus.
• Second trimester (14-20weeks of gestation).
• Normal Hemoglobin level: more than10g\dl.
• Serum ferritin less than 15 mcg / L

Exclusion Criteria

• Other type than iron-deficiency anemia (thalassemia, hemolytic anemia … etc.)
• Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases … etc.)
• Having hypersensitivity to iron preparations.
• Treatment with any other iron preparation in the last month.
• History of peptic ulcer, oesophagitis or hiatal hernia.
• Medical disorders with pregnancy.
• Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
• Bleeding in early pregnancy.
• Refusal to participate in the study.
• Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
• Recent blood transfusion.
• Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohamed Ahmed

Resident of O&G

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada Mohamed, MBBCh

Role: PRINCIPAL_INVESTIGATOR

G Darwish

Locations

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Countries

Egypt

Other Identifiers

LactvsFerr

Identifier Type: -

Identifier Source: org_study_id