Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Iron Deficiency Anemia Clinical Trial

Official title:

A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759353
• Other study ID #: LactvsFerr
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: November 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 20, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Diagnostic Test:
• Baseline ferritin level
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.

Drug:
• 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).
• 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.

Diagnostic Test:
• Follow up ferritin level
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum ferritin level	Change in serum ferritin level between enrollment and 4 weeks post-treatment.	4 weeks
Secondary	Nausea and/or vomiting	Incidence of treatment-related nausea and/or vomiting	4 weeks
Secondary	Dyspepsia	Incidence of treatment-related dyspepsia	4 weeks
Secondary	Compliance to treatment	Number of missed doses of treatment from the assigned 30 doses	4 weeks