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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinica Fabia Mater
• Treatments: Iron; Lactoferrin

Criteria

Inclusion Criteria:

• pregnant women with one of genetic thrombophilia markers as factor V Leiden, prothrombin 20210A mutation, antiphospholipid antibodies, hyperhomocysteinemia and deficiencies of antithrombin, protein C, or protein S.

• pregnant women affected by HT and suffering of iron deficiency (ID) and iron deficiency anemia (IDA)

• different trimester of pregnancy

• previous miscarriage/s

• previous preterm delivery/ies

• iron disorders as iron deficiency and iron deficiency anemia are defined by the number of red blood cells <4.000.000/mL, the hemoglobin concentration ≤ 11 g/dL, the total serum iron ≤ 30 mg/dL and serum ferritin ≤12 ng/mL.

Exclusion Criteria:

• absence of iron deficiency and iron deficiency anemia

• non-pregnant women

• uncomplicated pregnancies

• no informed consent

• other treatments of iron supplementation

• recent blood transfusion

• other concomitant diseases

• ascertained allergy to milk proteins or to iron products.