The Use of Liposomated Iron After Bariatric Surgery in Patients That Are Receiving Parentheral Therapy With Iron
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute