The Use of Liposomated Iron After Bariatric Surgery in Patients That Are Receiving Parentheral Therapy With Iron

NCT ID: NCT02390921

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-11-30

Brief 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.

Detailed Description

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.

Conditions

Liposomated Iron; Y-de-Roux Gastric By-Pass; Parenteral Iron Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liosomated iron therapy

Fisiogen Ferro Forte 28mg every day po, during 3 months

Group Type: ACTIVE_COMPARATOR

Fisiogen Ferro Forte

Intervention Type: DRUG

The patients will interrupt the endovenous treatment with iron and will receive liposomated iron 28mg/daily during 3 months.

Endovenous Iron Therapy

Venofer 300mg endovenously every 3 months

Group Type: EXPERIMENTAL

Venofer

Intervention Type: DRUG

The patients will continue their usual endovenous administration of Venofer 300mg every 3 month

Interventions

Fisiogen Ferro Forte

The patients will interrupt the endovenous treatment with iron and will receive liposomated iron 28mg/daily during 3 months.

Intervention Type: DRUG

Venofer

The patients will continue their usual endovenous administration of Venofer 300mg every 3 month

Intervention Type: DRUG

Other Intervention Names

Oral treatment with liposomated iron (Fisiogen Ferro Forte); Endovenous treatment with Venofer 300mg every 3 month

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreea Ciudin

Role: PRINCIPAL_INVESTIGATOR

Vall d´Hebron University Hospital

Locations

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

PR(AG)275/2014

Identifier Type: -

Identifier Source: org_study_id