Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Iron Deficiency Anemia

Treatments: Drug: Lactoferrin; Diagnostic Test: Follow up ferritin level; Drug: Ferrous Sulfate; Diagnostic Test: Baseline ferritin level

Study type: Interventional

Funder types: Other

Identifiers

NCT03759353

LactvsFerr

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Lactoferrin Group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Follow up ferritin level

Diagnostic Test: Baseline ferritin level

Drug: Lactoferrin

Ferrous Sulfate Group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Follow up ferritin level

Drug: Ferrous Sulfate

Diagnostic Test: Baseline ferritin level