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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
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.
Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt
Change in serum ferritin level
Change in serum ferritin level between enrollment and 4 weeks post-treatment.
Time frame: 4 weeks
Nausea and/or vomiting
Incidence of treatment-related nausea and/or vomiting
Time frame: 4 weeks
Dyspepsia
Incidence of treatment-related dyspepsia
Time frame: 4 weeks
Compliance to treatment
Number of missed doses of treatment from the assigned 30 doses
Time frame: 4 weeks
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