Liposomated IronPhase 4BARIFERNCT02390921
The Use of Liposomated Iron After Bariatric Surgery in Patients That Are Receiving Parentheral Therapy With Iron
A Phase 4 study testing Fisiogen Ferro Forte and Venofer in people with Liposomated Iron and Y-de-Roux Gastric By-Pass, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Liposomated Iron, Y-de-Roux Gastric By-Pass, Parenteral Iron Therapy
- What is being tested?
- Fisiogen Ferro Forte and Venofer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic 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.
Read more
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.
Read the 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.
- Being tested
- Fisiogen Ferro Forte, Venofer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisiogen Ferro ForteDrug
Also called Oral treatment with liposomated iron (Fisiogen Ferro Forte)
The patients will interrupt the endovenous treatment with iron and will receive liposomated iron 28mg/daily during 3 months.
VenoferDrug
Also called Endovenous treatment with Venofer 300mg every 3 month
The patients will continue their usual endovenous administration of Venofer 300mg every 3 month
| Study group | Role | What they receive |
|---|---|---|
| Liosomated iron therapy | Active comparator | Fisiogen Ferro Forte 28mg every day po, during 3 months Receives: Drug: Fisiogen Ferro Forte |
| Endovenous Iron Therapy | Experimental | Venofer 300mg endovenously every 3 months Receives: Drug: Venofer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority (change in the levels of Hemoglobin)
To evaluate the change in the levels of Hemoglobin at 4 and 12 weeks of treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liposomated IronStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreea Ciudin, Principal investigator, Vall d´Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390921
- Sponsor's protocol ID
- PR(AG)275/2014
- Acronym
- BARIFER
- Status last verified
- Apr 2017
- First submitted
- 5 Feb 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic Parentheral Therapy With Iron
- ClinicalTrials.gov ID
- NCT02390921
- Acronym / sponsor ID
- BARIFER / PR(AG)275/2014
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liosomated iron therapy | Active comparator | Drug: Fisiogen Ferro ForteFisiogen Ferro Forte 28mg every day po, during 3 months |
| Endovenous Iron Therapy | Experimental | Drug: VenoferVenofer 300mg endovenously every 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In the clinical study will include:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fisiogen Ferro ForteAlso: Oral treatment with liposomated iron (Fisiogen Ferro Forte)The patients will interrupt the endovenous treatment with iron and will receive liposomated iron 28mg/daily during 3 months. | Drug | Liosomated iron therapy |
| VenoferAlso: Endovenous treatment with Venofer 300mg every 3 monthThe patients will continue their usual endovenous administration of Venofer 300mg every 3 month | Drug | Endovenous Iron Therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreea Ciudin principal investigator
Vall d´Hebron University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fisiogen Ferro Forte and Venofer in people with Liposomated Iron and Y-de-Roux Gastric By-Pass, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority (change in the levels of Hemoglobin) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.