Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated … (NCT01221844) | Clinical Trial Compass
CompletedPhase 4
Bovine Lactoferrin to Prevent and Cure Iron Deficiency and Iron Deficiency Anemia in Complicated Pregnancies
Italy300 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
20 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hematological parameters
Timeframe: At time 0 (enrollement) and every 30 days until delivery (6-8 months)