Ferinject in patients with iron deficiency after primary RYGB. Which therapy is the most effective one to replace ironstorage?We also analyse the interval between initiation of therapy and adequate correction of iron deficiency.
ID
Source
Brief title
Condition
- Iron and trace metal metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum ferritin, iron, hemoglobin, transferrin saturation, and transferrin after
6, 12 and 52 weeks after administration of ferrous fumarate, Losferron or
Ferinjet.
Secondary outcome
Evaluate patients' preference of the route of administration : administered
orally (ferrous fumarate / Losferron) or intravenously (Ferinject).
Background summary
The number of people with morbide obesitas in the Western World has increased a
lot the past 10 years. During this period the number of bariatric procedures in
the Netherlands increased from a 1000 interventions in the year 2000 to 9000
interventions in 2012. Bariatric sprocedures can be divided in restrictive
techniques, malabsorptieve techniques or a combination of both. The Adjustable
Gastric Band (AGB) an the Gastric Sleeve (GS) are knows as restrictive
technique, the Roux-en-Y gastric bypass (RYGB) is a combined technique with an
average weight loss of 60-70 %. Unfortunately vitamin and mineral deficiencies
are a consistent effect of the malabsorptie and reduced intake after the
surgery. Iron deficiency is known in 14-66% of the cases in the first two years
after surgery. A postoperative identified irondeficiency will be supplied with
oral ironsupplements. There are three preparations who are used worldwide. The
most common oral preparations are ferrous fumarate and Losferron
(ferrogluconaat). When deficiency doesn*t improve with oral supplements
patients will be treated with Ferinject (iron(III)carboxymaltose).
It is of importance to treat an irondeficiency to prevent a microcytic anemia
and fatigue caused by irondeficiency.
The risk of developing iron deficiency anemia after RYGB is the most high in
premenopausal women.
Study objective
Ferinject in patients with iron deficiency after primary RYGB. Which therapy is
the most effective one to replace ironstorage?
We also analyse the interval between initiation of therapy and adequate
correction of iron deficiency.
Study design
A prospective radomised controlled trial will be performed with 240 patients
who underwent a primary RYGB and postoperatively develop a irondeficiency
(ferritin < 20 microgram/l). Women (group 1) and men (group 2) will be
seperated in 2 groups of 120 patients. Irondeficiency is identified during the
postoperative follow-up (standard follow-up moments in our centre: 6,12,24 and
36 months).
Group 1 and 2 will be randomised in 3 treatment groups: treatment with ferrous
fumarate, losferron (ferrogluconate) or ferinject.
- Group 1A: irondeficiency in this women will be corrected by ferrous fumarate
200mg 3 times daily.
- Group 1B: irondeficiency in this women will be corrected by losferron 695mg 2
times daily.
- Group 1C: irondeficiency in this women will be corrected by a single shot
Ferinject, dosage will be examined for each patient individually. The
intravenous injection will be performed in the cilinical day centre.
- Group 2A: irondeficiency in this men will be corrected by ferrous fumarate
200mg 3 times daily.
- Group 2B: irondeficiency in this men will be corrected by losferron 695mg 2
times daily.
- Group 2C: irondeficiency in this men will be corrected by a single shot
Ferinject, dosage will be examined for each patient individually. The
intravenous injection will be performed in the cilinical day centre.
The effect of different ironsuppletions on the serum ferritin will be evaluated
6 weeks after starting treatment. When ironlevels awill not be normalized,
treatment will be continued and follow-up will be performed 12, 26 and 52 weeks
after starting therapy, including blood samples for ferritin.
During the appointments a questionairre will be filled in to evaluate the route
of administration preference of the patient (oral suppletion vs. intravenous
injection).
Study burden and risks
benefit, because it is the standard treatment for irondeficiency.
The study is designed to optimize the treatment for irondeficiency developed
after RYGB and to evaluate the most preferred suppletionmethod for the patient.
Patients who have an irondeficiency are treated with ferrous fumarate or
Losferron (group 1A, 1B and 2A and 2B).
Group 1C, and 2C are treated with Ferinject. These patients (group C) may have
the advantage that after one intravenous injection the serum ferritin
normalizes and no further treatment is needed, they do not need daily
administered oral iron suppletion. Patients in the Ferinject-group need to stay
a half day in the hospital. The possible disadvantages can be the side effects
of Ferinject (see protocol).
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
All patients who underwent a gastric bypass and developped an irondeficiency postoperatively (ferritin< 20 microfram/l) ,age between 18-65 years
Exclusion criteria
iron deficiency preoperatve, bloodtransfusions during study period, ironcontaining nutritional supplements except the 'standard' multivitamins after bariatric surgery, decreased renal failure, excessive manstruational blood loss, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for one of the medicinal products, psychiatric illness, pregnancy.;Acute and chronic infection or other inflammationreactions, liver dysfunction.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002322-12-NL |
| CCMO | NL49631.091.14 |