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
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
- Pregnancy
- Iron Deficiency
- Iron Deficiency Anemia
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
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