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

NCT01221844 | Completed Phase 4

• 1 other identifier: RP2010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lactoferrin; Pregnancy; Hereditary Thrombophilia; Iron deficiency; Iron deficiency anemia

Outcome Measures

Primary Outcomes (1)

• Hematological parameters

  Efficacy of bLf versus ferrous sulfate in preventing and curing iron deficiency and iron deficiency anemia

  At time 0 (enrollement) and every 30 days until delivery (6-8 months)

Secondary Outcomes (1)

• Side effects

  6-8 months

Study Arms (2)

Lactoferrin treatment in HT pregnacies

EXPERIMENTAL

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

Ferrous sulfate in HT pregnancies

ACTIVE COMPARATOR

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

Interventions

Lattoglobina (Grunenthal) containing bLf DIETARY_SUPPLEMENT

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

Also known as: Commercialization by Grunenthal Italy, Manifacture by Giellepi, Licence Microbo srl, Rome, Italy

Lactoferrin treatment in HT pregnacies

FerroGrad by Abbott DRUG

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

Also known as: FerroGrad, Abbott

Ferrous sulfate in HT pregnancies

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Fabia Mater: lead

Study Sites (1)

Clinica Fabia Mater

Rome, Rm, Italy

Location

Related Publications (6)

• Paesano R, Berlutti F, Pietropaoli M, Goolsbee W, Pacifici E, Valenti P. Lactoferrin efficacy versus ferrous sulfate in curing iron disorders in pregnant and non-pregnant women. Int J Immunopathol Pharmacol. 2010 Apr-Jun;23(2):577-87. doi: 10.1177/039463201002300220.

  PMID: 20646353 BACKGROUND

• Paesano R, Berlutti F, Pietropaoli M, Pantanella F, Pacifici E, Goolsbee W, Valenti P. Lactoferrin efficacy versus ferrous sulfate in curing iron deficiency and iron deficiency anemia in pregnant women. Biometals. 2010 Jun;23(3):411-7. doi: 10.1007/s10534-010-9335-z. Epub 2010 Apr 21.

  PMID: 20407805 BACKGROUND

• Paesano R, Pietropaoli M, Gessani S, Valenti P. The influence of lactoferrin, orally administered, on systemic iron homeostasis in pregnant women suffering of iron deficiency and iron deficiency anaemia. Biochimie. 2009 Jan;91(1):44-51. doi: 10.1016/j.biochi.2008.06.004. Epub 2008 Jun 14.

  PMID: 18601971 BACKGROUND

• Paesano R, Torcia F, Berlutti F, Pacifici E, Ebano V, Moscarini M, Valenti P. Oral administration of lactoferrin increases hemoglobin and total serum iron in pregnant women. Biochem Cell Biol. 2006 Jun;84(3):377-80. doi: 10.1139/o06-040.

  PMID: 16936810 BACKGROUND

• Lepanto MS, Rosa L, Cutone A, Conte MP, Paesano R, Valenti P. Efficacy of Lactoferrin Oral Administration in the Treatment of Anemia and Anemia of Inflammation in Pregnant and Non-pregnant Women: An Interventional Study. Front Immunol. 2018 Sep 21;9:2123. doi: 10.3389/fimmu.2018.02123. eCollection 2018.

  PMID: 30298070 DERIVED

• Paesano R, Pacifici E, Benedetti S, Berlutti F, Frioni A, Polimeni A, Valenti P. Safety and efficacy of lactoferrin versus ferrous sulphate in curing iron deficiency and iron deficiency anaemia in hereditary thrombophilia pregnant women: an interventional study. Biometals. 2014 Oct;27(5):999-1006. doi: 10.1007/s10534-014-9723-x. Epub 2014 Mar 4.

  PMID: 24590680 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency; Thrombophilia, hereditary

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Rosalba Paesano, Dr

  Clinica Fabia Mater, Via Olevano Romano 25, Rome (Italy)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 15, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

IT (1)