Liposomated Iron Clinical Trial
— BARIFEROfficial title:
The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic Parentheral Therapy With Iron
| Verified date | April 2017 |
| Source | Hospital Universitari Vall d'Hebron Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | November 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - In the clinical study will include: - women who underwent Y-de-Roux gastric by-pass - over 18 years, premenopausal - stable weight in the previous 6 months - currently receiving parenteral iron therapy regularly in solitary day hospital - which have signed the informed consent Exclusion Criteria: - male - with mobility problems that constrain a marked inactivity - with associated disease (chronic obstructive pulmonary cardiac cerebral vascular-disease, illness, accident sequel , severe psychiatric or eating disorder - undergoing different surgical techniques to gastric bypass - other causes of iron deficiency. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Vall d'Hebron | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitari Vall d'Hebron Research Institute |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Non-inferiority (change in the levels of Hemoglobin) | To evaluate the change in the levels of Hemoglobin at 4 and 12 weeks of treatment | 3 months |