Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies
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.
|Pregnancy Iron Deficiency Iron Deficiency Anemia||Dietary Supplement: Lattoglobina (Grunenthal) containing bLf Drug: FerroGrad by Abbott||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- 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
- Side effects [ Time Frame: 6-8 months ]
Control of side effects of oral administration of bLf and ferrous sulfate as:
- gastrointestinal discomfort
|Study Start Date:||February 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221844
|Clinica Fabia Mater|
|Rome, Rm, Italy|
|Study Chair:||Rosalba Paesano, Dr||Clinica Fabia Mater, Via Olevano Romano 25, Rome (Italy)|