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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221844
First Posted: October 15, 2010
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Clinica Fabia Mater
  Purpose

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.


Condition Intervention Phase
Pregnancy Iron Deficiency Iron Deficiency Anemia Dietary Supplement: Lattoglobina (Grunenthal) containing bLf Drug: FerroGrad by Abbott Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of Oral Administration of Bovine Lactoferrin (bLf) to Prevent and Cure Iron Deficiency (ID) and Iron Deficiency Anemia (IDA) Until Delivery in Hereditary Thrombophilia (HT) Affected Pregnant Women

Resource links provided by NLM:


Further study details as provided by Clinica Fabia Mater:

Primary Outcome Measures:
  • Hematological parameters [ Time Frame: At time 0 (enrollement) and every 30 days until delivery (6-8 months) ]
    Efficacy of bLf versus ferrous sulfate in preventing and curing iron deficiency and iron deficiency anemia


Secondary Outcome Measures:
  • Side effects [ Time Frame: 6-8 months ]

    Control of side effects of oral administration of bLf and ferrous sulfate as:

    • gastrointestinal discomfort
    • nausea
    • vomiting
    • diarrhea
    • constipation


Estimated Enrollment: 300
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactoferrin treatment in HT pregnacies
Pregnant women affected by HT, ID and IDA are enrolled and treated until delivery with oral administration of one capsule of 100 mg of bLf (Lattoglobina, Grunenthal, Italy) twice a day before meals. In twin pregnancies or in severe anemia, HT pregnant women are treated until delivery with two capsules of 100 mg of bLf twice a day, before meals.
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
Other Names:
  • Commercialization by Grunenthal Italy
  • Manifacture by Giellepi
  • Licence Microbo srl, Rome, Italy
Active Comparator: Ferrous sulfate in HT pregnancies
Pregnant women affected by HT, ID and IDA are enrolled and treated until delivery with oral administration of 520 mg of ferrous sulfate (Ferro-Grad, Abbott Laboratories, USA), once a day during meal.
Drug: FerroGrad by Abbott
Dosage: one tablet/day containing 540 mg of ferrous sulfate during meals
Other Names:
  • FerroGrad
  • Abbott

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221844


Locations
Italy
Clinica Fabia Mater
Rome, Rm, Italy
Sponsors and Collaborators
Clinica Fabia Mater
Investigators
Study Chair: Rosalba Paesano, Dr Clinica Fabia Mater, Via Olevano Romano 25, Rome (Italy)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rosalba Paesano, Clinica Fabia Mater, Rome (Italy)
ClinicalTrials.gov Identifier: NCT01221844     History of Changes
Other Study ID Numbers: RP2010
First Submitted: October 12, 2010
First Posted: October 15, 2010
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Clinica Fabia Mater:
Lactoferrin
Pregnancy
Hereditary Thrombophilia
Iron deficiency
Iron deficiency anemia

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Thrombophilia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Lactoferrin
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents