NCT02390921: BARIFER

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

Completed Phase 4 Last updated 11 April 2017

What this trial tests

Phase 4 trial testing Fisiogen Ferro Forte in Liposomated Iron in 40 participants. Completed in 1 November 2015.

Timeline

1 February 2015

Primary endpoint
1 October 2015

1 November 2015

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 February 2015
Primary completion	1 October 2015
Estimated completion	1 November 2015
Sites	1 location across Spain

Drugs / interventions tested

• Fisiogen Ferro Forte — full drug profile →
• Venofer

Conditions studied

• Liposomated Iron — all drugs for Liposomated Iron →
• Y-de-Roux Gastric By-Pass — all drugs for Y-de-Roux Gastric By-Pass →
• Parenteral Iron Therapy — all drugs for Parenteral Iron Therapy →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

18 and older, female only, with Liposomated Iron or Y-de-Roux Gastric By-Pass. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.