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Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy

NCT03759353 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2018-11-30

No results posted yet for this study

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

Interventions

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).

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.

DIAGNOSTIC_TEST

Follow up ferritin level

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ghada Mohamed, MBBCh · G Darwish

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2018-10-30
Completion
2018-11-20

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759353 on ClinicalTrials.gov