Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Phase 2

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Diagnostic Test: Baseline ferritin level; Drug: Ferrous Sulfate; Drug: Lactoferrin; Diagnostic Test: Follow up ferritin level

• Registration Number: NCT03759353
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Primary Completion: 2018-10-30
• Status Verified: 2018-11
• Study Completion: 2018-11-20
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-30
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin Group	Baseline ferritin level	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.
Ferrous Sulfate Group	Baseline ferritin level	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.
Ferrous Sulfate Group	Ferrous Sulfate	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.
Ferrous Sulfate Group	Follow up ferritin level	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.
Lactoferrin Group	Follow up ferritin level	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.
Lactoferrin Group	Lactoferrin	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.

Primary Outcome Measures

Name	Time	Method
Change in serum ferritin level	4 weeks	Change in serum ferritin level between enrollment and 4 weeks post-treatment.

Secondary Outcome Measures

Name	Time	Method
Nausea and/or vomiting	4 weeks	Incidence of treatment-related nausea and/or vomiting
Dyspepsia	4 weeks	Incidence of treatment-related dyspepsia
Compliance to treatment	4 weeks	Number of missed doses of treatment from the assigned 30 doses

Trial Locations

Locations (1)

Ain SHams Maternity Hospital; 🇪🇬 Cairo, Abbaseya, Egypt