Liposomated Iron Clinical Trial
Official title:
The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic Parentheral Therapy With Iron
Bariatric surgery is the most effective long-term treatment of morbid obesity treatment, so
you can maintain weight loss enduringly with improvement or resolution of comorbidity and
mortality reduction. All bariatric surgery techniques in postoperative induce a significant
reduction in food intake and / or absorption of nutrients and therefore may be associated
with a risk of nutritional deficiency, which increases over the years after surgery. One of
the nutrients whose absorption is affected significantly is iron, women of childbearing age
segment most vulnerable being. A significant percentage of these women require oral
supplementation with high doses of iron and often parenteral treatment is needed for
digestive intolerance or therapeutic failure.
Hypothesis: The liposome orally administered iron could represent a therapeutic alternative
in women of childbearing age, previously undergone bariatric surgery that currently require
parenteral iron therapy.
Objectives: To evaluate the tolerability and efficacy of oral iron liposome female patients
previously undergone bariatric surgery that currently require parenteral replacement
therapy, as well as the impact on quality of life.
Methods: a single center, open, prospective, interventional, in 40 women of childbearing
age, previously undergone bariatric surgery, which currently require intravenous iron
therapy chronically. Subjects will be divided into 2 parallel groups: 20 cases and 20
controls matched for age, level of Hb, year after surgery and percentage of weight lost.
Relevance: This study will allow us to identify an alternative treatment with oral iron in
the case of patients with severe iron deficiency after bariatric surgery, which currently
require parenteral iron therapy due to intolerance to current oral products or therapeutic
failure. At the same time it could help reduce healthcare costs and improve the quality of
life of these patients, who will not have to enter periodically in solitary day hospital for
administration of parenteral iron.
This project is proposed with the aim of exploring the efficacy and tolerability of liposome
orally administered iron in female patients previously undergone bariatric surgery (gastric
bypass) currently receiving parenteral iron therapy chronically.
The hypotheses are:
(i) .- A significant percentage of patients undergoing bariatric surgery have iron
deficiency and chronic complication. In the investigators series, approximately 100 women
require intravenous iron therapy in a chronic (10% of all patients undergoing bariatric
surgery to date), significantly increasing costs.
(ii) .- The liposomal form of iron does not depend on gastric pH and increased
bioavailability is not dependent on the presence of the digestive dudodeno circuit.
(iii) .- Increased iron absorption and tolerability allow us to remove chronic intravenous
iron therapy in the case of these patients. Thus, majoraria quality of life by reducing
healthcare costs and avoiding adverse reactions associated with the procedure.
Main objective: To evaluate the tolerability and efficacy of oral iron liposome female
patients previously undergone bariatric surgery that currently require parenteral
replacement therapy for chronic form.
Secondary objectives:
(i) .- To evaluate the change in the levels of Hb, ferritin, iron, transferrin saturation at
4, 12 weeks of treatment.
(ii) .- Lay the foundation for future study of pharmacokinetics and pharmacodynamics in
patients undergoing bariatric surgery.
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