Skip to main content
OpenTrials
Completed

NCT Number: NCT02390921

The Use of Liposomated Iron After Bariatric Surgery in Patients That Are Receiving 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fisiogen Ferro Forte

Drug

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

Other names: Oral treatment with liposomated iron (Fisiogen Ferro Forte)

Venofer

Drug

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

Other names: Endovenous treatment with Venofer 300mg every 3 month

Primary outcomes

  1. Non-inferiority (change in the levels of Hemoglobin)

    Time frame: 3 months

    To evaluate the change in the levels of Hemoglobin at 4 and 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic Parentheral Therapy With Iron

Acronym: BARIFER

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.