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

NCT02390921 | Completed Phase 4

• 1 other identifier: PR(AG)275/2014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Liosomated iron therapy

ACTIVE COMPARATOR

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

Drug: Fisiogen Ferro Forte

Endovenous Iron Therapy

EXPERIMENTAL

Venofer 300mg endovenously every 3 months

Drug: Venofer

Interventions

Fisiogen Ferro Forte DRUG

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

Also known as: Oral treatment with liposomated iron (Fisiogen Ferro Forte)

Liosomated iron therapy

Venofer DRUG

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

Also known as: Endovenous treatment with Venofer 300mg every 3 month

Endovenous Iron Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Interventions

Therapeutics; Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Andreea Ciudin

  Vall d´Hebron University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: March 18, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)