Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies

NCT01221844 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-06-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether bovine lactoferrin is effective in preventing and curing iron deficiency and iron deficiency anemia in Hereditary Thrombophilia affected women during pregnancy.

The proposed clinical trial is considered as PHASE IV because in Italy bLf is commercialized by Grunenthal, as Lattoglobina® (capsules with 100 mg of bLf), to prevent and cure iron deficiency and iron deficiency anemia in pregnant women.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lattoglobina (Grunenthal) containing bLf

One capsule of Lattoglobina contains 100 mg of bLf. Dosage: one capsule twice a day before meals. In twin pregnancy or in severe anemia the dosage is increased to 2 capsules twice a day before meals

DRUG

FerroGrad by Abbott

Dosage: one tablet/day containing 540 mg of ferrous sulfate during meals

Sponsors & Collaborators

  • Clinica Fabia Mater

    lead OTHER

Principal Investigators

  • Rosalba Paesano, Dr · Clinica Fabia Mater, Via Olevano Romano 25, Rome (Italy)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT01221844 on ClinicalTrials.gov