Evaluate if ironabsorption is disturbed after a RYGB, which leads to a insufficient treatment of oral ironsuppletion. Analyse if failure of oral ironsuppletion is predictable at baseline (T=0) in the absorption test.
ID
Source
Brief title
Condition
- Iron and trace metal metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Iron values in the blood before and 1,2,3,4,5 and 6 hours after the
administration of oral ironreplacement in micrograms / dl.
Secondary outcome
The difference between pre- and postoperative absorptionvalues.
Background summary
There are indications that the absorption of oral iron supplementation is
reduced after a RYGB. Nevertheless, oral preparations are used as standard
therapy for iron deficiency, even in patients who underwent a RYGB. To take a
better look at the absorption of iron after a gastric bypass, we'll perform an
ironabsorption test in the period pre- and postoperative. This part of the
study will be performes only in the Rijnsate Hospital in Arnhem.
Hyopthesis: when the ironabsorption test shows major differences in absorption
after a RYGB, we may predict in the future the effectiviness of oral
ironsuppletion.
Study objective
Evaluate if ironabsorption is disturbed after a RYGB, which leads to a
insufficient treatment of oral ironsuppletion.
Analyse if failure of oral ironsuppletion is predictable at baseline (T=0) in
the absorption test.
Study design
Prospective monocentre study (only in the Rijnstate Hospital Arnhem).
Twenty-four patients will perform an ironabsorption test pre- and
postoperatively. There will be 2 groups ( each group contains 12 patients).
Preoperatively: group 1 receives a daily dose of ferrous fumarate (600mg) and
group 2 receives a daily dose Losferron (1390mg).
Before intake of the medicins, a fasting bloodsample is taken (baseline), serum
iron including ferritin, transferrin and transferrin saturation will be
measured. After intake of losferron/ferrous fumarate blood samples will be
taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80
microgram/l is representative for a sufficient ironabsorption.
Postoperatively; one month postoperatively the same absorption test will be
repeated in the same patients.
Study burden and risks
Participants in this study will not experience a direct benefit. The study was
set up to optimize iron suppletion in patienst who developed a irondeficiency
after RYGB. Irondeficiency is frequently seen after a RYGB. A ironabsorption
test will be performed. Participants receive in the periode before and after
the operation a single dose Losferron / ferrous fumarate. An infusion is
aplied. Blood will be collected from the applied infusion, in total 14 times: 7
times preoperatively and 7 times postoperatively
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Patients who are eligible for a primary Roux- en -Y gastric bypass and have no pre-existing iron deficiency (serum ferritin of 20-200 micrograms / L), age between 18-65 years.
Exclusion criteria
-bloodtransfusion one month before and in the study period
-the use of ironcontaining nutritional supplements, except our standardized multivitamin supplements.;-decreased function of the kidney with a GFR of < 30ml/min and/or serum kreatinin below 50micromol/L;-Hb < 7,4 mmol/L in females and Hb < 8.4mmol/L in males;-accumulation of iron;- iron diseases;- hypersensitivity for one of the medicinal products ;- psychiatric illness;-pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002323-10-NL |
| CCMO | NL49646.091.14 |